Device evaluated by manufacturer? no.The device for this complaint was not returned for evaluation.However, the lens was returned and visual inspection found the lens to be stuck in the returned injector.There was no visible damage to the injector and there was evidence of clear surgical residue.Event problem and evaluation codes: method: (process evaluation): cartridge lot search, injector lot search.Results: (evaluation result): a cartridge lot search found no similar complaints.An injector lot search found no similar complaints.Conclusion: (unable to confirm complaint): based on the complaint history, visual inspection of the returned product, cartridge and injector lot searches, a specific root cause of the event could not be determined.(b)(4).Cartridge was not returned.
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Method: device history record review, work order search.Results: upon review of the device history record, there is nothing in the manufacturing, inspection and packaging process records that suggests a contributory factor to the complaint.A work order search found no similar complaints.Conclusion: 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).
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