Model Number MX60E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Vitreous Loss (2142); Capsular Bag Tear (2639)
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Event Date 10/26/2022 |
Event Type
Injury
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Manufacturer Narrative
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Although requested, the device was not returned for evaluation.Investigation is ongoing and a follow-up report will be submitted upon completion of investigation.
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Event Description
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It was reported that after the implantation of an intraocular lens in the left eye, a capsular bag broke causing vitreous loss.A vitrectomy was performed one day post-op and the lens was exchanged with a three-piece lens.Patient outcome is good.Additional information has been requested.
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Manufacturer Narrative
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Additional information was received indicating the device causality was unrelated, and therefore, this event no longer meets reportability requirements and no longer deemed reportable.
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Event Description
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Additional information received indicating that in the surgeon's opinion the most likely cause of the event was the fluid burst, which is related to the handpiece and i/a.
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Search Alerts/Recalls
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