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.Device evaluation: product evaluation could not be performed since the product was not returned for evaluation.According to the action/evaluation description section the product was discarded.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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) was fully inserted, removed and replaced during the same procedure, had to do vitrectomy.A non-johnson and johnson lens was used instead.The suspect product was discarded.The patient recovered.It was also learned there was capsule tear, but no product quality issue.No other information was provided.
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