(ethnicity): unknown/ not provided.Asku.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.The device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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It was reported that an intraocular lens (iol) is being defective.The lens did not unfold when it was released from the cartridge.It was replaced with back-up lens same model and diopter size as suspect iol.There was no incision enlargement, vitrectomy, sutures done.No patient post-op injury.It was wasted/ the suspect product was discarded.No other information was provided.
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