The device was returned for evaluation.Visual inspection found that the lens was cut in two (2) pieces across the optic, a small cut was located near the edge and a haptic was broken.The surface of the lens and haptics had an orange peel appearance.Analysis of the returned device was completed using optical inspection, laser confocal microscopy, scanning electron microscopy, and electron dispersive x-ray spectroscopy.It was determined that the opacification was due to the presence of patchy, textured or wrinkled deposits on the anterior iol surface comprised primarily of calcium and phosphorous.Additional deposits containing calcium and phosphorous were also sparsely observed on the posterior lens surface and the haptics.Results of the analysis can best be described as opacification due to calcification.The 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/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the evaluated suspect device, the root cause is "known procedure complication".
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