[188207914]
The intraocular lens (iol) was returned in a plastic specimen cup. The original packaging was not returned, however, the reported lens identification information was written on the label. The lens was in two pieces, as the optic had been cut or torn in half. Three haptic arms were torn off and missing. The fourth haptic arm was bent. Functional testing cannot be performed due to the damage. The cause of the damage cannot 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 review are considered acceptable, with the product performing within anticipated rates. The most probable root cause is that this event is patient-related. In the surgeon? S opinion, the most likely cause of the event was asymmetrical posterior capsule contraction causing z-tilt of optic. No corrective action is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[188207915]
It was reported that approximately six weeks post implant of an intraocular lens (iol) in the left eye (os), that the patient developed z- optic tilt. The patient noticed a decrease in their vision. Iol repositioning / rotation was successfully performed three days post event, but z tilt reoccurred approximately three weeks later. An iol explant and replacement was successfully performed four and half months post original implant using an iol of a different model, but the same diopter. There were no complications with the original surgery. The iol optic was free and clear of any debris. In the physician? S opinion the most likely cause was asymmetrical posterior capsule contraction causing z-tilt of optic. The patient current prognosis is recovering from iol exchange. Patient prognosis is good.
Patient Sequence No: 1, Text Type: D, B5