Real-World Safety Profile of EVO and EVO+ Implantable Collamer Lenses: A Retrospective Study Based on FDA Surveillance Data

Abstract

Introduction

To evaluate and characterize adverse events (AEs) associated with EVO and EVO+ implantable collamer lens (ICL) using real-world post-marketing surveillance data from the Food and Drug Administration (FDA)'s MAUDE database.

Methods

A retrospective analysis was conducted on AE reports related to EVO and EVO+ ICLs, including both spherical and toric models, submitted between 2015 and 2023. After excluding duplicate entries and incomplete records, reports were stratified by lens model and optical type into four groups: spherical EVO, toric EVO, spherical EVO+, and toric EVO+. Each report was independently reviewed by two senior ophthalmologists to classify the associated complications. Descriptive statistics were used to evaluate the proportional distribution of complications across subgroups and to assess the annual trend in reported AEs.

Results

A total of 17,482 AEs reports were analyzed. Across all subgroups, over half of the reports documented no clinical signs or symptoms. Blurred vision was the most frequently reported visual complaint, with a relatively higher reporting frequency in the EVO+ groups. Events involving elevated intraocular pressure and glaucoma were more commonly reported among EVO+ recipients. In addition, a number of rare but clinically significant complications were documented, including hemorrhage, hyphema, decreased intraocular pressure, endophthalmitis, and toxic anterior segment syndrome. The annual number of reported AEs showed a consistent upward trend throughout the study period.

Conclusion

This real-world data analysis provides insights into the distribution of major complications associated with ICL implantation in clinical practice. Comprehensive identification and reporting of rare adverse outcomes may help surgeons broaden their perspectives, enhance surgical preparedness, and provide more personalized and informed preoperative counseling.

Supplementary Information

The online version contains supplementary material available at 10.1007/s40123-025-01222-y.

Key Summary Points

Why carry out this study?

Previous studies have shown that implantable collamer lens (ICL) surgery has been associated with a range of complications, but current literature is limited by small sample sizes, underreporting, potential bias, and financial relationships between authors and device manufacturers.

Complications involving EVO and EVO+ ICL reported to the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database have not previously been described.

What was learned from the study?

Across all subgroups (spherical EVO, toric EVO, spherical EVO+, and toric EVO+), blurred vision, elevated intraocular pressure, and glaucoma were reported, with a relatively higher proportion in the EVO+ groups.

Rare but clinically significant complications were also documented, including hemorrhage, hyphema, decreased intraocular pressure, endophthalmitis, and toxic anterior segment syndrome.

The annual number of reported adverse events showed a consistent upward trend throughout the study period, highlighting the need for sustained attention to the safety profile of ICL implantation and the importance of ongoing post-market surveillance.

Introduction

Myopia has emerged as a global public health challenge, with projections estimating that by 2050, half of the world’s population will be affected [1]. This trend carries substantial socioeconomic implications and drives ongoing innovation in refractive correction technologies. Implantable collamer lens (ICL, STAAR Surgical, Nidau, Switzerland), a posterior chamber phakic intraocular lens, is increasingly recognized as a valuable alternative for corneal refractive surgeries, particularly for patients with high refractive errors or thin corneas.

The ICL has seen exponential growth in clinical adoption, with global implantation numbers rising from 1 million in 2019 to over 3 million by 2024, with 2.5 million of these being EVO ICLs [2, 3]. The EVO (introduced in 2011) and EVO+ (2015) models are among the most widely adopted posterior chamber pIOLs for refractive correction [4–6]. Featuring a central KS-AquaPORT that eliminates the need for preoperative iridotomy, these lenses offer excellent safety and efficacy. EVO+ additionally boasts a larger optical zone diameter, improving quality of vision in dim light conditions [7].

Despite its growing popularity, ICL surgery has been associated with a range of complications, including residual astigmatism, transient intraocular pressure (IOP) elevation, and lens misalignment, as well as rare but serious events such as cataract formation, endothelial cell loss, and retinal detachment [5, 8]. One single-center study reported no major adverse events (AEs) but did find that 18.1% of toric ICL (TICL) eyes were predicted to have > 1D residual cylinder, and 4.8% required secondary interventions such as rotation or enhancement [9]. Postoperative IOP spikes occurred in 19.9% of eyes in the US Food and Drug Administration (FDA) trial, with 1.1% requiring explantation or further surgery [5]. Endothelial cell loss rates vary between 0.1% and 22.0%, and cataract incidence between 0% and 3.85%, and the risk of postoperative endophthalmitis, though rare, remains a clinically important concern [10, 11].

Current literature is limited by small sample sizes, underreporting, potential bias, and financial relationships between authors and device manufacturers [12]. To address these limitations and provide a more comprehensive safety profile, this study utilizes the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database—the largest publicly accessible repository of AEs related to EVO and EVO+ series of ICL, including both standard ICL and toric ICL (TICL) models in the United States. This database has been widely utilized in research to investigate AEs associated with various medical technologies, including assistive technologies in ophthalmic surgeries [12], ophthalmic injectable drugs [13], and human implants [14, 15]. By leveraging real-world post-marketing surveillance data, this analysis aims to identify the most clinically significant complications of ICL surgery, improve understanding of its safety profile, and offer evidence-based insights to refine surgical practice.

Methods

We conducted a retrospective analysis of AEs associated with EVO and EVO+ ICL implantation between 2015 and 2023 using post-marketing surveillance data from the publicly accessible FDA MAUDE database (https://www.fda.gov/). The data on ICL and TICL are provided in Supplemental Data Files 1 and 2. Established in the 1990s and updated monthly, the MAUDE database includes information on event date, reporter occupation, ICL model and manufacturer, patient demographics, and narrative descriptions of adverse events.

Duplicate entries were identified and excluded based on identical report numbers, web address, device problem, patient problem, and highly similar report narratives. In cases where duplicates were detected, the most complete version of the report was retained. Reports lacking lens diopter information or with insufficient detail to determine the nature of the complication were excluded. The remaining reports were categorized into four groups based on lens model and optical correction type: EVO ICL, EVO TICL, EVO+ ICL, and EVO+ TICL.

Each report was independently reviewed manually by two senior clinicians without the use of automated software tools. Complications were categorized based on clinical judgment. If multiple complications were described in a single report, each was recorded and analyzed separately. Summary statistics were calculated for patient demographics, patient complications, and occupation of the individual submitting the report. The annual numbers of AEs were also assessed.

This study was conducted in accordance with the principles of the Declaration of Helsinki. As the MAUDE data are de-identified and publicly available, this study did not constitute human subjects research and was exempt from institutional review board (IRB) approval. Given the nature of the dataset, only descriptive statistical analyses were performed, and differences between groups were interpreted descriptively rather than inferentially. All statistical analyses were performed using R software (version 4.3.1).

Results

As Tables 1, 2, 3, and 4 show, a total of 17,482 adverse event reports related to EVO and EVO+ ICL implantations were extracted from the MAUDE database, including 6816 cases in the ICL (myopia only) group and 10,666 in the TICL (myopia with astigmatism) group. The analysis focused on the proportional distribution of reported complications rather than true incidence rates, in accordance with the nature of surveillance data.

Table 1.

Demographic and baseline clinical factors of included patients (EVO and EVO+ ICL)

Patient age at surgery (years)	ICL
	EVO (n = 4641)	EVO+ (n = 2175)
< 21	365	96
21–25	1004	356
26–30	1001	464
31–35	1024	353
36–40	615	250
41–45	267	171
> 45	329	274
Missing age	137	336
Gender
Female	1841	717
Male	551	414
Not reported	2249	1044
Year
2015	120	0
2016	190	20
2017	155	67
2018	115	122
2019	133	186
2020	449	232
2021	1325	433
2022	1021	516
2023	1083	599
Reporter occupation
Non-healthcare professional	2	0
Other	7	5
Other healthcare professional	12	96
Patient	2	0
Physician	3818	1588
Physician assistant	4	4
Not reported	796	482

ICL implantable collamer lens

Table 2.

Demographic and baseline clinical factors of included patients (EVO and EVO+ TICL)

Patient age at surgery (years)	TICL
	EVO (n = 7221)	EVO+ (n = 3445)
< 21	1010	175
21–25	1758	677
26–30	1705	689
31–35	1212	575
36–40	714	346
41–45	297	249
> 45	351	352
Missing age	386	567
Gender
Female	3028	1107
Male	1353	946
Not reported	2840	1392
Year
2015	120	0
2016	156	6
2017	198	77
2018	158	125
2019	211	189
2020	612	400
2021	1865	670
2022	1789	758
2023	2112	1220
Reporter occupation
Administrator/supervisor	0	1
Non-healthcare professional	6	2
Other	23	3
Other healthcare professional	39	112
Patient	3	0
Physician	6135	2668
Physician assistant	6	6
Not reported	1009	653

TICL toric implantable collamer lens

Table 3.

Distribution of ICL-associated complications by category

ICL complications
	EVO (4641)		EVO+ (2175)
	N	%	N	%
No patient impact
No clinical signs, symptoms, or conditions	3370	72.61%	1223	56.23%
No consequences or impact to patient	167	3.59%	51	2.34%
No known impact or consequence to patient	244	5.25%	141	6.48%
No patient involvement	11	0.23%	43	1.98%
Vision issues
Blurred vision	368	7.92%	317	14.57%
Fatigue	1	0.02%	1	0.05%
Halo	115	2.47%	122	5.61%
Visual disturbances	107	2.31%	129	5.93%
Visual impairment	8	0.17%	0	0
IOP issues
Eye pain	10	0.21%	4	0.18%
Glaucoma	4	0.08%	5	2.30%
Headache	24	0.52%	23	1.06%
Intraocular pressure increased	222	4.78%	150	6.89%
Intraocular pressure, delayed, uncontrolled	3	0.06%	2	0.09%
Nausea	1	0.02%	1	0.05%
Pain	31	0.67%	14	0.64%
Pupillary block	16	0.34%	13	0.64%
Vomiting	2	0.04%	0	0
Lens-related issues
Capsular bag tear	2	0.04%	1	0.05%
Cataract, induced	11	0.23%	2	0.09%
Cataract	46	0.99%	39	1.80%
Intraocular inflammation and infection
Endophthalmitis	17	0.37%	17	0.78%
Hypopyon	2	0.04%	0	0
Inflammation	11	0.23%	26	1.20%
Intraocular infection	1	0.02%	0	0
Iritis	2	0.04%	5	0.23%
Toxic anterior segment syndrome (TASS)	2	0.04%	13	0.60%
Uveitis	0	0	7	0.32%
Cornea issues
Corneal abrasion	1	0.02%	0	0
Corneal clouding/hazing	0	0	1	0.05%
Corneal decompensation	2	0.04%	4	0.18%
Corneal edema	17	0.37%	24	1.10%
Corneal touch	2	0.04%	1	0.05%
Corneal ulcer	1	0.02%	0	0
Keratitis	0	0	1	0.05%
Other
Hemorrhage/bleeding	1	0.02%	0	0
Hyphema	3	0.06%	0	0
Obstruction/occlusion	2	0.04%	0	0
Retinal detachment	2	0.04%	2	0.04%
Vitrectomy	2	0.04%	0	0

ICL implantable collamer lens

Table 4.

Distribution of TICL-associated complications by category

TICL complications
	EVO (7221)		EVO+ (3445)
	N	%	N	%
No patient impact
No clinical signs, symptoms, or conditions	5482	75.92%	2136	62.00%
No consequences or impact to patient	105	1.45%	51	1.48%
No known impact or consequence to patient	242	3.35%	124	3.60%
No patient involvement	17	0.24%	27	0.78%
Vision issues
Blurred vision	678	9.39%	649	18.84%
Fatigue	2	0.03%	1	0.03%
Halo	160	2.22%	109	3.16%
Loss of vision	1	0.01%	0	0
Visual disturbances	159	2.20%	0	0
Visual impairment	15	0.21%	1	0.03%
IOP issues
Eye pain	11	0.15%	8	0.23%
Glaucoma	8	0.11%	9	0.26%
Headache	20	0.28%	23	0.67%
Intraocular pressure decreased	1	0.01%	0	0
Intraocular pressure increased	310	4.29%	181	5.25%
Intraocular pressure, delayed, uncontrolled	5	0.07%	0	0
Nausea	4	0.06%	0	0
Pain	29	0.40%	26	0.75%
Pupillary block	30	0.42%	22	0.64%
Vomiting	4	0.06%	4	0.12%
Lens-related issues
Capsular bag tear	1	0.01%	0	0
Cataract	51	0.71%	33	0.96%
Cataract, induced	6	0.08%	0	0
Intraocular inflammation and infection
Cyclitis	1	0.01%	0	0
Endophthalmitis	7	0.10%	6	0.17%
Hypopyon	1	0.01%	2	0.06%
Inflammation	27	0.37%	31	0.90%
Iritis	3	0.04%	12	0.35%
Toxic anterior segment syndrome (TASS)	5	0.07%	10	0.29%
Uveitis	9	0.12%	9	0.26%
Cornea issues
Clouding, central corneal	0	0	1	0.03%
Corneal clouding/hazing	1	0.01%	0	0
Corneal decompensation	8	0.11%	5	0.15%
Corneal edema	30	0.42%	32	0.93%
Corneal touch	1	0.01%	0	0
Corneal ulcer	0	0	1	0.03%
Edema	38	0.53%	35	1.02%
Keratitis	0	0	1	0.03%
Other
Hyphema	1	0.01%	1	0.03%
Retinal detachment	3	0.04%	1	0.03%
Vitrectomy	2	0.03%	1	0.03%
Intraocular pressure decreased	1	0.01%	0	0
Macular edema	2	0.03%	2	0.06%

TICL toric implantable collamer lens

Overall Safety Profile and Asymptomatic Reports

The majority of reports across all subgroups indicated no clinical signs, symptoms, or adverse outcomes, with over 70% of EVO cases in both ICL and TICL cohorts labeled as “no clinical signs, symptoms, or conditions.” The proportion decreased slightly in EVO+ cases (56.23% in ICL and 62.00% in TICL), suggesting a trend toward higher reporting of symptoms with the newer lens generation.

Visual Symptoms and Generation Differences

Blurred vision was the most frequently reported visual symptom and occurred significantly more often in EVO+ recipients. In the TICL cohort, the rate increased from 9.39% (EVO) to 18.84% (EVO+), and similarly in the ICL cohort from 7.92% to 14.57%. Reports of halos and general visual disturbances also increased with EVO+.

Intraocular Pressure Elevation and Glaucoma Risk

Intraocular pressure elevation was frequently reported across all subgroups, particularly in EVO+ cases. In the ICL group, IOP increase was reported in 6.89% of EVO+ cases compared to 4.78% in EVO. The difference was also present in patients with TICL (5.25% vs. 4.29%). EVO+ implantation in patients with ICL was associated with a marked increase in glaucoma diagnoses (2.30% vs. 0.08% in the ICL group, 0.26% vs. 0.11% in the TICL group).

Ocular Inflammation and Infectious Events

Though infrequent, inflammatory complications such as uveitis and iritis were more frequently reported in the EVO+ TICL subgroup, indicating possible enhanced immunologic reactivity in these patients. Additionally, rare but vision-threatening complications including endophthalmitis (up to 0.78% in EVO+ ICL subgroup) and toxic anterior segment syndrome were reported more often with EVO+ lenses. These findings underscore the value of the MAUDE database in identifying low-incidence but clinically significant events.

Corneal Complications and Lens-Associated Issues

Corneal edema was the most common corneal adverse event, observed more often in EVO+ (1.10% in ICL and 0.93% in TICL) than in EVO (0.37% in ICL and 0.42% in TICL). Reports of corneal decompensation, ulcers, and keratitis, though rare (defined in this study as < 10 reported cases), occurred exclusively or more frequently in the EVO+ group. Cataract formation and lens-related issues (e.g., lens dislocation, induced cataract) were infrequent (10–100 reported cases), but cataract development was more common in EVO+ (1.80% in ICL and 0.96% in TICL) than EVO (0.99% in ICL and 0.71% in TICL). Given that over 3 million EVO and EVO+ ICLs have been implanted worldwide, a complication occurring in fewer than 10 cases corresponds to a population-level prevalence of less than 0.33 per 100,000, supporting the classification of such events as rare in this context.

Identification of Rare but Serious Complications

The MAUDE database enabled identification of ultra-rare events, such as hemorrhage, hyphema, decreased IOP, endophthalmitis, hypopyon, and toxic anterior segment syndrome, many of which were limited to single-digit occurrences or rates below 0.1%. While there is no universally accepted threshold for defining "rare" in ophthalmic device complications, in this study, we considered events occurring in fewer than 10 cases (among over 3 million ICL implantations globally) to be rare. This classification aligns with international epidemiological definitions of rarity. For example, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) reported that most jurisdictions consider a prevalence of < 40–50 per 100,000 as “rare” [16]. Similarly, the EU defines rare diseases as those affecting fewer than 5 in 10,000 individuals, and the US threshold is < 200,000 individuals nationwide[17, 18]. Our operational definition therefore provides a conservative and globally consistent framework for interpreting low-frequency events. Although these events are unlikely to be captured in clinical trials due to their rarity, they may carry serious consequences, thereby reinforcing the utility of large-scale post-market surveillance systems.

Discussion

This study, based on MAUDE post-market surveillance data, revealed a noticeable increase in the proportion of reported blurred vision, halos, and increased IOP following EVO+ ICL implantation compared to the earlier EVO model. While both lenses have demonstrated excellent safety and efficacy in clinical trials [4–6], the real-world scope of MAUDE provides insight into complication trends across a wider range of ophthalmologists and practice settings.

A key finding was that blurred vision, halos, and other visual disturbances were the most commonly reported adverse events in both the EVO and EVO+ groups, with these events constituting a relatively higher proportion in the EVO+ group. While long-term safety is well maintained, efficacy may decrease subtly, with progressive refractive fluctuations reported in some cohorts [19–22]. This decline may be associated with axial elongation [23]. However, because the timing of AEs is not reliably reported in the MAUDE database, such associations with post-implantation processes remain speculative. This limitation should be considered when interpreting these findings.

It is worth noting that although the EVO+ model is designed for patients with larger pupils to improve night vision quality, this study found a higher proportion of halos and other visual disturbances in the EVO+ group. Previous research by Ieong et al. reported that driving in glare conditions became more difficult after ICL surgery [24]. Factors associated with the occurrence of halos include the ICL’s optic zone diameter, the discrepancy between mesopic pupil size and ICL optic zone diameter, and the white-to-white corneal diameter [25]. In particular, when pupil diameter exceeds the optical zone of the ICL—especially under mesopic or scotopic conditions—more peripheral light can enter through uncovered areas, leading to increased higher-order aberrations (HOAs), glare, and halos. Although EVO+ is often selected for large pupils, these patients may be at greater risk of visual disturbances if the optic zone does not fully cover the functional pupil area. Therefore, the very anatomical feature that indicates EVO+ use may also contribute to a more pronounced manifestation of optical side effects in certain lighting conditions. Additionally, a recent review suggested that HOAs—which contribute to halos and reduced night vision—can be induced by multiple factors, such as the size and location of the corneal incision, lens optics (e.g., magnification or spherical aberration), and the centration or tilt of the ICL during implantation [26]. Notably, ocular HOAs increase with pupil diameter [27, 28]. Since EVO+ is typically chosen for patients with larger pupils, the corneal incision may be closer to the optical center, increasing the risk of inducing HOAs. HOAs may also be elevated due to the ICL's inherent optical characteristics or the surgical technique itself [26, 29]. Moreover, the larger optic zone of EVO+ reduces the available surgical workspace in the anterior chamber, potentially increasing surgical complexity during ICL unfolding, centration, and thorough removal of ophthalmic viscosurgical device (OVD). This may contribute to greater postoperative inflammation and adverse events. These anatomical and procedural factors may explain the higher frequency of AEs observed in the EVO+ group despite its design intention to improve visual quality in large-pupil patients.

Apart from the vision issues, increased IOP was frequently reported across all subgroups, particularly in EVO+ cases. Current studies show that the central port in the EVO and EVO+ lens models allows the physiological flow of aqueous humor through the lens, eliminating the need for peripheral iridotomy prior to implantation, and reducing rates of anterior subcapsular cataract and pupillary block compared with earlier models [30]. However, the presence of the central hole in the ICL may not completely eliminate the occurrence of complications. Six-month results of a multicenter clinical trial revealed that increased IOP was the most commonly reported AE. The researchers attributed the increased IOP to residual ophthalmic viscosurgical device (OVD) (usually occurring 1–6 h after surgery) or to steroid response (occurring 6 to 31 days after surgery) [5]. The thorough removal of OVD depends not only on the type of viscoelastic substances used [31], but also on the surgeon’s experience. For ICLs of the same overall diameter, the larger optic zone in the EVO+ model reduces the available surgical workspace, increasing technical difficulty. This may hinder thorough OVD removal, prolong operative time, and exacerbate postoperative inflammation, potentially resulting in greater corticosteroid use. Furthermore, other potential causes of post-ICL IOP elevation include pupillary block, iris pigment dispersion, and a narrow anterior chamber angle [31]. A previous study demonstrated that greater iris area loss per millimeter increase in pupil diameter was independently associated with a higher risk of angle closure [32]. Since the use of the EVO+ lens is often associated with larger pupil sizes, and a higher proportion of glaucoma cases were observed in the EVO+ group than EVO, stricter preoperative screening and closer postoperative follow-up are recommended for patients with large pupils undergoing ICL implantation.

While many of the above factors explaining the increased frequency of visual disturbances and elevated IOP in the EVO+ group are well documented, they may not fully capture all underlying causes. Notably, the increase in complication reporting may also reflect heightened clinical vigilance or reporting bias toward newer-generation devices. As the EVO+ was more recently introduced, surgeons may have adopted stricter postoperative monitoring protocols or been more inclined to report adverse events associated with a newer model. Additionally, the learning curve specific to EVO+ implantation—given its larger optic zone and altered handling characteristics—may have contributed to early procedural variability and transient complication peaks. These possibilities, though speculative, highlight the complex interplay between device design, surgical practice, and reporting behavior, which may collectively influence observed complication trends. Further prospective and comparative studies are warranted to disentangle these factors.

As expected, most of the AEs identified in this study—such as blurred vision, halos, elevated IOP, glaucoma, cataract, and corneal edema—are well-documented complications associated with EVO and EVO+ ICL. Several of the complications reported to the MAUDE database, such as hemorrhage, hyphema, decreased intraocular pressure, endophthalmitis, and toxic anterior segment syndrome, are highly unusual. While their absolute frequencies were low, their presence in a passive reporting system highlights MAUDE’s critical role in capturing rare events that might go unobserved in clinical trials due to limited sample size, short follow-up, or strict inclusion criteria. These cases underscore the necessity of continuous post-market surveillance, especially when new device generations are introduced.

The present study identified a year-over-year increase in the number of ICL-related events reported in the MAUDE database (Fig. 1), suggesting that a growing number of individuals may be affected by ICL-associated complications. These findings underscore the need for sustained attention to the safety profile of ICL implantation and the importance of ongoing post-market surveillance.

Fig. 1.

Annual distribution of reports for spherical and toric EVO and EVO+ lenses (2015–2023). ICL implantable collamer lens, TICL toric implantable collamer lens

Several limitations should be acknowledged. First, due to the absence of a known denominator, it was not possible to calculate the incidence or prevalence of complications; only the proportion of each complication could be determined. Nevertheless, these proportions still provide valuable insights into the relative significance and ranking of complications associated with ICL surgery. Furthermore, the data were reported from a wide range of medical centers, and variations in the recognition and reporting of complications among different reporters may have introduced reporting bias. However, this diversity in surgical expertise, clinical experience, and complication awareness among centers may also enhance the real-world relevance of the findings, offering broader clinical applicability and a more comprehensive reflection of complication patterns in diverse practice settings. Additionally, the MAUDE reports typically lack detailed follow-up information regarding the management or resolution of the recorded complications. As a result, this study could not evaluate treatment strategies or clinical outcomes, which limits the interpretation of the potential severity or prognosis of these adverse events. For instance, although elevated intraocular pressure (IOP) was among the most frequently reported complications, the dataset does not provide sufficient clinical information—such as optic nerve status, visual field data, or treatment response—to determine whether sustained IOP elevation led to glaucomatous damage. Therefore, the magnitude and long-term consequences of such events remain uncertain.

Conclusion

In summary, this real-world analysis of MAUDE data revealed subtle yet clinically relevant differences in complication profiles between the EVO and EVO+ ICL models. In addition to confirming known issues such as blurred vision, halo, and increased IOP, the findings highlight a broader spectrum of adverse events observed in real-world practice. This expanded perspective is particularly valuable given the relative rarity of many of these complications. A comprehensive understanding of potential risks can help surgeons better anticipate surgical challenges and provide tailored preoperative counseling. Furthermore, the rising number of ICL-related adverse event reports in the FDA MAUDE database underscores the need for continued vigilance and research into the long-term safety of ICL implantation. Future prospective, multicenter studies with standardized reporting protocols are needed to better quantify complication rates and improve risk assessment before ICL surgery.

Supplementary Information

Below is the link to the electronic supplementary material.

Author Contributions

Qing Chen, MD, carried out the data collection and analysis and wrote the main manuscript. Shouxiang Ni, MD, reviewed the data, and wrote and revised the manuscript critically for important intellectual content. Haijing Yan, MD, provided assistance with statistics and data interpretation. Qinxiang Zheng, MD, and Yueping Ren, MD, contributed to the conception and design of the study, reviewed the data, and classified the associated complications.

Funding

No funding or sponsorship was received for this study or publication of this article. The Rapid Service Fee was funded by the authors.

Data Availability

The datasets analysed during the current study are available in the U.S. FDA MAUDE (Manufacturer and User Facility Device Experience) database. Further details or processed data used in this analysis are available from the corresponding author upon reasonable request.

Declarations

Conflict of Interest

All authors (Qing Chen, Shouxiang Ni, Haijing Yan, Qinxiang Zheng, Yueping Ren) have nothing to disclose. The authors have no financial or proprietary interests related to the subject matter.

Ethical Approval

This study was conducted in accordance with the principles of the Declaration of Helsinki. As the MAUDE data are de-identified and publicly available, this study did not constitute human subjects research and was exempt from institutional review board (IRB) approval.