According to the reporter, device was discarded and is not available for evaluation.As a lot number for the reported device was not provided, a dhr review could not be performed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have caused or contributed to this event.
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Reportedly, after implantation of an intraocular lens (iol) into the left eye it was discovered that iol haptics were bent.The surgeon attempted to straighten the haptics and during the process the iol flipped over and scratched the cornea.On post-op visit it was discovered that lens had shifted causing pain and visual problems for the patient.The lens was explanted 3 days post implant due to lens dislocation and extruded lens in the anterior chamber.A vitrectomy was performed, and the lens was replaced with another iol of the same model and diopter.
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