If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(4).Device evaluation: the device was not returned at the manufacturing site as it was discarded; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaints for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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It was reported that after the intraocular lens (iol) was implanted there was zonular dehiscence, therefore, the lens was removed during the same-procedure.A vitrectomy, incision enlargement, and sutures were required.The lens replaced with a non-johnson & johnson iol.The removed lens was discarded.The patient is reported to be doing ok.No additional information was provided.
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