The lens was not received by the manufacturer for analysis.
The relationship between the device and the adverse event is inconclusive, however we do not believe it is manufacturing related.
Iol met all manufacturing specifications prior to release.
Iol not returned.
It was reported that the patient developed endophthalmitis postoperative cataract surgery and intraocular lens implant.
The inflammation was treated without success by washing the eye.
The iol was removed and replaced with a different model.
Patient's condition is stable.