Model Number SOFTECHD+19.5 |
Device Problem
Device Handling Problem (3265)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/03/2021 |
Event Type
Injury
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Event Description
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Lenstec received an email stating " the posterior loop of the lens was found broken when doing the surgery.The broken lens was explanted after enlarged the incision, and another softec hd was implanted.".
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Manufacturer Narrative
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A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.The visual inspection performed on the device determined that the damage to the lens is consistent with the lens being caught and pulled in the injector.The injector used was not part of lenstec's validated device delivery systems for use listed in the ifu.Lenstec cannot comment of the compatability of the injector that was used with the this lens.
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Search Alerts/Recalls
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