Even though requested, the device was not returned for evaluation as it was discarded.The device history record (dhr) review, did not find any non-conformities or anomalies related to the reported event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Reportedly, a forceps was used to implant this device.According to the dfu, the use of an approved delivery device is recommended and therefore, the most likely root cause of this event is user related.
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Reportedly, an intraocular lens was implanted by a forceps.Approximately four months post-op, patient noticed a decrease in their vision.Due to a broken haptic-eyelet junction, the lens had post-operatively dislocated.Lens was explanted and replaced with a different model lens.Vitrectomy was performed and sutures were required.The patient's current outcome is good.
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