Model Number MXPL0200 |
Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/29/2022 |
Event Type
Injury
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Event Description
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Reportedly during delivery of the device the leading haptic came out straight.The surgeon removed the lens and used a backup lens which had the trailing haptic snap at the optic/haptic junction.The second lens was cut and removed from the patient¿s eye.Patient left the facility aphakic and returned the next week.A new lens of unknown model and diopter was implanted with no issues.Additional information was requested but not received.This report correlates to iol 2 of 2.
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Manufacturer Narrative
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The device has been discarded and is not available for evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.Investigation of this event is in progress and a follow-up will be submitted upon completion of investigation.
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Manufacturer Narrative
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The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Corrective measures have been identified to mitigate future similar occurrences.Bausch & lomb will continue to monitor similar events to determine if additional actions are required.
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Search Alerts/Recalls
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