If implanted; give date: n/a (not applicable).The healon pro is not an implantable device.If explanted; give date: n/a (not applicable).The healon pro is not an implantable device.The device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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It was reported that tass case occurred in a patient.Healon pro, lot# uh31179 and healon endocoat, lot# 028612, were used.It was stated that this case was the last case of the day.The patient was treated with moxifloxacin (antibiotic) 6 times a day, durezol q1-2h and medrol dose pack.At last appointment, vision is improving.The customer do not have the product to return for evaluation.Both the healon pro and healon endocoat are kept in the refrigerator until the morning of the case.The temperature log that day did not show any changes in temperature that would be out of the normal range.This report represents the complaint against the healon pro.A separate report is being submitted for the healon endocoat.
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