Section d10.Device available for evaluation? yes.Returned to manufacturer on: 1/6/2021.Section h3.Device returned to manufacturer? yes.Device evaluation: returned lens was received, submerged in an unknown solution inside a specimen cup.Additional documentation was received as well.The lens was cleaned and visual inspection under magnification revealed, that the lens was returned cut in half with a bent haptic.Which may have occurred, when the lens was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed.And no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed, that there was no discrepancy found during the review.The product was manufactured and released according to specifications.A search revealed, that two additional complaints were received from this production order, but no product malfunction or discrepancy could be identified.And no escalation is required.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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