Model Number MX60PL |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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Although requested, the device was not returned for evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies related to this event.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all the available information, the root cause of this event could not be determined.
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Event Description
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The healthcare facility reported a damaged haptic during an intraocular lens (iol) implant.The incision was enlarged to remove the lens and no sutures were required.The procedure was completed with a replacement lens of the same model and diopter.Additional information has been requested.
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Manufacturer Narrative
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Our assessment of this event remains the same.
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Event Description
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Additional information was received indicating the event was associated with the fork of the inserter.Allegedly once it was pushed, it caused breakage of the iol.
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Manufacturer Narrative
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Although the iol was not returned for evaluation, additional investigation on the returned injector indicated a plunger fork damage which results when the plunger is not fully retracted and the plunger safety is not engaged and/or if the shuttle is not completely snapped into the injector.Based on the available information, unintended user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and injector interaction) may have contributed to the event.
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Search Alerts/Recalls
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