Date of event: unknown, not provided, but the best estimate date is during (b)(6) 2017.If implanted, give date: not applicable as this is not an implantable device f explanted, give date: not applicable as this is not an implantable device manufacturing date: unknown as lot number was not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
|
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: as the lot number is unknown for this event, it is not possible to perform any manufacturing record evaluation or complaint history review.Labeling review: as the lot number is unknown for this event, it was not possible to perform a labeling review.As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|