Date of event: unknown, not provided.If implanted, give date: unknown, information not provided.(b)(6).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing process record was evaluated, and no nonconformance reports or discrepancies were found during the mrr (manufacturing record review) related to this complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed no additional complaint was received from this production order number.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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