Patient age and date of birth, patient weight, and ethnicity and race: unknown as information was asked, but not provided.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted; therefore, not explanted.Device evaluation: the product testing could not be performed as the product was not returned for evaluation (the device was discarded).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed and no non-conformance report (nc) was found as part of this manufacturing records review.The product was manufactured and released according to specification.A search in complaint system revealed that no other complaints were received for 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.Attempts were made to contact the customer account requesting additional information regarding complaint 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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