Though requested, the device has not been returned for evaluation.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.According to the available information, the most likely cause of the iol damage was the lens getting stuck between the cartridge and the plunger.User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.
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It was reported that during implantation of an intraocular lens (iol) into the left (os) eye, it was noticed intraoperatively that the trailing haptic was severed.The incision original size of 2.4mm was enlarged to 3.0mm for iol removal.A successful intraoperative lens exchange was performed using a backup iol of the same model and diopter.Sutures were required.The patient did not notice a decrease in vision at the 1 week post op visit.In the surgeon's opinion, the most likely cause of the iol damage was the lens getting stuck between the cartridge and the plunger.The patient's outcome is good.
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