Age or date of birth, weight, and ethnicity: per regulation (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.The best estimate date is between the implantation on (b)(6) 2022 and the post-operative check-up on (b)(6) 2022.Initial reporter telephone number: (b)(6).Device evaluated by mfr: - other (81): the device is not returning for evaluation 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.(b)(4).Attempts have been made to obtain the missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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It was reported that the patient complained about her vision.She was not happy with the result of her surgery during her post-operative examination on the (b)(6) 2022.A secondary surgery took place to reposition the luxated intraocular lens (iol).During the procedure it was observed, that the haptic of the lens was broken off, so the lens did not stay in position.The capsular bag was intact and the broken off haptic was not found in the eye.The iol was explanted and replaced with a new lens.No further information was provided.
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