It was reported that an intraocular lens (iol), model diu525, 17.0 diopter was exchanged for a diu375 lens of the same diopter due to mechanical failure.No surgical and/or medical interventions required, and no patient injury reported.No further information was provided.
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Section a4 and a5: unknown, information was requested but not provided.Section b3: date of event: exact date is unknown/not provided.Best estimate date is between (b)(6) 2023.Section h3-other (81): 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.An attempt was made to obtain the missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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