Initial reporter telephone number: (b)(6).Device evaluated by mfr: other (81): a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Device available for evaluation? yes returned to manufacturer: yes returned to manufacturer date: 11/14/2022 device evaluated by manufacturer? yes section h6 coding type of investigation: 10 investigation findings: 213.Device evaluation: 1 opened opos20l phaco irrigation sleeve and tip were received within a resealable bag.A visual inspection of the returned product did not reveal any obvious defects or damage.The phaco tip and sleeve were attached to a known good phaco ellips fx handpiece.The tip and sleeve were not found to be loose and the phaco tip could not be removed by hand.The returned tip and sleeve were attached to an ellips fx phaco handpiece (e202839) and a known good opo73 phaco pack (lot# 60212251) on the whitestar signature pro.Prime/tune was commenced and completed successfully.The tip and sleeve were not found to be loose and the phaco tip could not be removed by hand.The reported issue could not be confirmed.Manufacturing record review: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing.All devices met material, assembly and performance specifications at the time of product released.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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