Pt info: unknown/ not provided.Date of event: unknown, not provided.Catalog number: partial catalog number indicated since the serial number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as the serial number was not provided.Udi number: a complete udi number is unknown, as the serial number was not provided.Implant date: unknown, information not provided.Explant date: not applicable, there is no indication the device was explanted.(b)(6).Device manufacture date: unknown as the serial number of the device was not provided.(b)(4).Device evaluation: the 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.An attempt has 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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