According to the reporter, the device was discarded and is not available for evaluation.A device history record (dhr) review, did not find any non-conformities or anomalies related to this event.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.In the surgeons opinion, the most likely cause of the iol damage was due to the plunger making the scratch in the optic.The most likely root cause for this event is operational context.User-related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to this event.No corrective action is necessary at this time.
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It was reported that during a procedure an intraocular lens (iol) was inserted in the patient¿s eye, when in the capsular bag it was noted that there was a scratch on the optic.The iol was removed from the patient's eye after enlarging the incision and no sutures were required.The original incision size was 2.2 mm and it was enlarged to approximately 2.8mm to remove the lens.The duration of the surgery was extended by approximately half an hour.A second iol of a different model was implanted.The patient reported edema post-surgery, which was resolved within one week.In the surgeon¿s opinion, the most likely cause of the iol damage was due to the injector making the scratch in the optic.
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