The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: sep 19, 2022 section h3: evaluated by manufacturer: yes device evaluation: the complaint lens was received cut in half which is consistent with a lens that was handled during explant.No further defects that could contribute to visual issues were observed.Based on the return condition of the lens no further product evaluation could be performed.The complaint issue ¿halo vision¿ was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: 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.
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