Model Number BL1UT2050125 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/27/2015 |
Event Type
Injury
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Manufacturer Narrative
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The lens has been returned and is currently being evaluated.Investigation is underway.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 during lens insertion, the trailing haptic detached from the optic.The leading haptic and optic were inside the eye and the trailing haptic was detached from the lens at the hinge; it stayed in the inserter.The implanted lens and haptic were cut and removed, and a backup lens was implanted with no issue.The physician believes a loading error occurred.The original incision was not enlarged but an additional incision was made for explantation.Protocol sutures were used.The patient's current prognosis is good.
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Manufacturer Narrative
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Only the haptic plate portion of the lens was returned.Due to the condition in which the lens was returned further testing could not be performed.A retain sample from lot# 7460210 was pulled for dimensional inspection.All dimensional measurements were found to be within specifications.The lot history record was reviewed and there were no non-conformities or anomalies related to this complaint.Based on the current information the exact root cause cannot be determined.However, it is possible that user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.
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Search Alerts/Recalls
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