The reporter stated the surgeon noted a defect in the leading haptc of a 13.7mm micl13.7 implantable collamer lens, -7.0 diopter.There was no patient contact and the backup lens was used.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
|
Method: (process evaluation): device history record review.Result: (no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion: (unable to confirm complaint): based on the complaint history, work order search, product evaluation, and device history record review, a specific root cause of the event could not be determined.(b)(4).
|