Section e1: initial reporter telephone number: (b)(6).Device evaluation: product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed because the serial number of the complaint product is unknown.Since the serial number is unknown, the complaint history review could not be performed.Conclusion: since the sample of the complaint product was not returned, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|