It was reported that after opening the side port during the surgery and injecting healonv into the anterior chamber, the physician noticed a foreign substance was mixed in, and it was removed afterwards.No other problem was observed, the surgery was completed successfully.No further information was provided.
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Section a2, a4 and a5: unknown, as information was requested but not provided.Section d6a - implant date: not applicable.Healon is not an implantable device.Section d6b - explant date: not applicable.Healon is not an implantable device.Section e1: first name: unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6).Section h3 - other (81): the healon was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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