(b)(4).A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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It was reported that during catalyst procedure, cataract incision would not seal.There was no patient injury and the procedure was completed successfully.Doctor had to use sutures.There were no vitrectomy or incision enlargement performed during procedure.Doctor completed incision with laser, there were toric marks, one mark was near the cataract incision.No additional information was provided.
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