Table 3.
Adverse Events and Secondary Surgical Interventions (Safety Analysis Set)
| First Eye (n = 73) | Second Eye (n = 68) | |||
|---|---|---|---|---|
| Preferred term | n (%) | E | n (%) | E |
| Posterior capsule opacification | 4a (5.5) | 4 | 2a (2.9) | 2 |
| Macular fibrosis | 3 (4.1) | 3 | 1 (1.5) | 1 |
| Punctate keratitis | 1 (1.4) | 2 | 0 | 0 |
| Glare | 1 (1.4) | 1 | 1 (1.5) | 1 |
| Macular holeb | 1 (1.4) | 1 | 0 | 0 |
| Ocular hyperemia | 1 (1.4) | 1 | 0 | 0 |
| Retinal injury | 1 (1.4) | 1 | 0 | 0 |
| Retinal pigment epitheliopathy | 0 | 0 | 1 (1.5) | 1 |
| Vision blurred | 1 (1.4) | 1 | 0 | 0 |
| Vitreous detachment | 1 (1.4) | 1 | 1 (1.5) | 1 |
| Ocular adverse device effects | ||||
| Vision blurred | 1 (1.4) | 1 | 0 | 0 |
| First Eye, n (%) | Second Eye, n (%) | |||
| Secondary surgical interventions | 0 | 0 | ||
| Subjective PCO or posterior capsulotomy | ||||
| None | 69 (94.5) | 66 (97.1) | ||
| Clinically nonsignificant | 1 (1.4) | 1 (1.5) | ||
| Clinically significant | 1 (1.4) | 1 (1.5) | ||
| Clinically significant requiring Nd:YAG treatment | 2 (2.7) | 0 | ||
| Posterior capsulotomy | 0 | 0 | ||
Notes: aTwo first eyes and one second eye had events described as posterior capsular plaques. bSerious adverse device effect.
Abbreviations: E, event; Nd:YAG, neodymium-doped yttrium aluminum garnet; PCO, posterior capsular opacity.