Model Number BL1UT |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 a lens was explanted a lens due to mechanical issue.Reportedly, the lens was not accommodating properly.Additional information has been requested but has not been received.
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Manufacturer Narrative
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The lens was returned to b+l.All dimensional measurements were found to be within specifications.Lens evaluation did not identify any anomaly with the lens.The device history records were reviewed and there were no discrepancies or unusual finding that relate to the reported issue.Based on the information available, the root cause of the reported event could not be determined.
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Search Alerts/Recalls
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