Implant date: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Explant date: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.The device was not returned for analysis as it was discarded.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.Attempts have been made to obtain the missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Additional information: following information was obtained from the patient label received along with the sample at the investigation label: section a2: date of birth: (b)(6)1956.Section b5: the first name of the surgeon was (b)(6).Section d9: device available for evaluation: yes section d9: returned to manufacturer on: jul 13, 2022 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.No iol was received as part of this return, therefore no product evaluation could be performed on the lens.Visual inspection under magnification of the handpiece revealed that it was received with the plunger rod fully advanced.The cartridge tip could be observed to be bent, in a way consistent with a handpiece that was dropped.The external assembly was inspected and, no issues that could cause or contribute to positioning issues during implantation could be identified.Conclusion: the reported complaint issues could not be confirmed, therefore cold not be confirmed to be related to a manufacturing or design issue.As no lens was returned there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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