Table 4.
The Nature and Incidence of Adverse Events
| Adverse Event | N (%) | Serious | Device Related | Status |
|---|---|---|---|---|
| Layered hyphema ≥ 1mm | 9 (6%) | No | Yes | Recovered spontaneously without sequel |
| Intraocular pressure increase ≥ 10 mmHg above baseline at ≥ 1 month | 3 (2.0%) | No | Yes | Recovered without sequel with hypotensive medication added |
| Blepharitis | 2 (1.3%) | No | No | Recovered spontaneously without sequel |
| Clinically significant cystoid macular edema | 1 (0.7%) | No | No | Recovered without sequel after topical steroid |
| Internal Hordeolum | 1 (0.7%) | No | No | Recovered without sequel after topical treatment |
| Keratoconjunctivitis sicca | 1 (0.7%) | No | No | Recovered without sequel after topical treatment |
| Vitreous Hemorrhage | 1 (0.7%) | No | No | Recovered spontaneously without sequel |
| Loss of 2 lines or more BCVA (10 or more ETDRS letters) at or after 3 months postoperative | 2 (1.3%) | No | No | VA loss due to PCO; ongoing |