It was reported an intraocular lens (iol) was explanted from the left (os) eye approximately one month after implant due to dislocation of the iol.A successful lens exchange using a different model lens was performed, however, the surgery was complicated as the replacement lens was an anterior chamber iol.There was no incision enlargement, but the surgeon used 10-0 monosoft sutures.In the surgeon's opinion, the most likely cause of the event was dislocation of the iol and the patient's outcome is reported to be good.
|
The product was returned and evaluated.Visual inspection found the intraocular lens (iol) cut in half.The haptics were bent and one haptic was torn at the base.Functional testing could not be preformed due to the damage and cause of the damage could not be determined.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.Based on the information provided, we are unable to determine a root cause.
|