Age or date of birth,weight and ethnicity: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy if explanted, give date: not applicable, as partially placed lens was removed/replaced in the initial surgery.If implanted, give date: not applicable, as partially placed lens was removed/replaced in the initial surgery.Initial reporter telephone number: (b)(6).Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record evaluation: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation was required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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