Additional information: age, date of birth, patient weight, ethnicity, and race: unknown as information was not provided.Date of event: unknown, the best estimate date is between 03-nov-2020 and 07-jun-2021.Date explanted: not applicable as the iol remains implanted in the patient's ocular sinister (left eye).It was indicated that the iol is not being returned for evaluation as it remains implanted in the patients os therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Corrected data: in further review of the file, it was noted that an incorrect date (09-jun-2021) was inadvertently entered in section 'g3 - date received by manufacturer' of the initial mdr report.The correct date which should have been entered is '23-jun-2021' which is the date that the follow-up information regarding yag procedure was received; therefore, the information has been corrected in this supplemental mdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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