Model Number MX60U |
Device Problems
Bent (1059); Delivery System Failure (2905); Device Damaged by Another Device (2915)
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Patient Problems
Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643)
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Event Date 01/12/2017 |
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 during operation the lens became stuck in the delivery device and one haptic was damaged.Surgeon had to remove the lens.Capsular bag was damaged and there was vitreous loss.The surgeon performed vitrectomy and implanted a 3 piece iol successfully.The patient's outcome is fine.
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Manufacturer Narrative
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The lens was not returned to b+l for evaluation.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.
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Search Alerts/Recalls
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