Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: exact date unknown, around 20 days prior to (b)(6) 2020.Catalog # and serial number: unknown/not provided.Lot#, udi# and expiration date: unknown/as serial number was not provided.If implanted; give date: n/a.Healon is not an implantable device.If explanted; give date: n/a.Healon is not an implantable device; therefore, not explanted.Reporter phone: (b)(6).Device manufacture date: unknown as serial number was not provided.(b)(4).Device evaluation: the healon unit was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be performed.Manufacturing record evaluation: the manufacturing records for the product could not be reviewed since no lot/serial number details could be obtained.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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