Model Number LI61AOR |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.
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Event Description
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It was reported that a lens haptic was found to be crushed during surgery, after implantation into the eye.As a result, the incision was enlarged in order to remove the lens and a same model lens was implanted with no issue.Patient was taken to recovery room in good condition.
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Manufacturer Narrative
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The lens was returned for evaluation.Visual inspection found both haptics bent.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the information provided, the root cause cannot be determined.However, it is likely that the user related factors and/or procedural factors may have caused or contributed to the event.
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Search Alerts/Recalls
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