If implanted; explanted; give date: n/a (not applicable).The cartridge is not an implantable device.Therefore, not explanted.(b)(6).The cartridge is not returning for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the lot history record, labeling, 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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