Model Number LI61AO |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/18/2016 |
Event Type
Injury
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Manufacturer Narrative
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Investigation of this event is in progress.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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It was reported that the lens was implanted and removed due to bent haptic.The incision was enlarged but no sutures were required.Back up lens was implanted with no issues.
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Manufacturer Narrative
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The device history record was reviewed and there were no discrepancies or unusual finding that relate to the reported issue.Based on the current information the root cause of the event could not be conclusively determined.However it is possible that user-related factors (such as loading or handling techniques) or procedural related factors (such as lens and inserter interaction) might have contributed to the event.
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Search Alerts/Recalls
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