Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).Healon is not an implantable device.If explanted; give date: n/a (not applicable).Healon is not an implantable device; therefore, not explanted.First name: unknown/ not provided.(b)(6).Device evaluation: the helaon product was not returned for evaluation as it was discarded after use; therefore, product testing could not be performed, and the customer's reported complaint could not be verified.Manufacturing record evaluation: the manufacturing records for the healon were reviewed and no deviation was found.The product was manufactured and released according to specification.A search in complaint system revealed that two similar complaints for this order number have been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported complaint could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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