Model Number MSI-PM |
Device Problem
Delivery System Failure (2905)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/20/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The injector was not returned, however , the lens was received and evaluated.There was a tear noted and a piece of the optic was torn off and missing.The was evidence of a clear surgical residue.L.(b)(4).
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Event Description
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The customer reported the +16.5 diopter aq2010v silicone three piece lens was torn by the injector during insertion.The lens was removed and replaced.No patient injury reported.
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Manufacturer Narrative
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(b)(4).Evaluation result: upon review of the device history record, there is nothing in the manufacturing, inspection and packaging process records that suggests a contributory factor in the complaint.A work order search was performed and no similar complaints were found.Conclusion: based on the complaint history, work order search, product evaluation, medical review, and device history record review, a specific root cause of the event could not be determined.Claim # (b)(4).
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Manufacturer Narrative
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Evaluation results: per medical review - reportedly, 3-piece silicone iol was torn during insertion requiring intraoperative lens removal/exchange.Another lens of same model and diopter was successfully implanted.Incision was not enlarged and no other tissue damage was reported.According to the report, by a nurse, dated on (b)(4) 2015, the most likely cause of the event was injector.Conclusion: (unable to confirm complaint); based on the complaint history, product evaluation, and medical review, a specific root cause of the event could not be determined.
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Search Alerts/Recalls
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