Model Number MX60E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Endophthalmitis (1835)
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Event Date 08/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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Device is not available for investigation as it remains implanted in the patient¿s eye.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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Approximately 8 months post implantation patient developed bilateral precipitates on the anterior of the lens.The surgeon believes the patient has chronic endophthalmitis.
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Event Description
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Additional information from the surgeon confirmed the results of the tap performed were negative.The precipitates disappeared with a steroid with no recurrence.There is currently pigments on the patients lens.
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Manufacturer Narrative
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A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information the root cause of this event could not be determined.
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Search Alerts/Recalls
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