If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.(b)(6).It was indicated that neither the device or the foreign material are returning for evaluation; 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 and johnson surgical vision, inc.Has been submitted.
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It was reported that a vial of viscoelastic healon contained a black strand.There was no patient injury.Reportedly, the issue was noted during surgery, the hair-like material was injected into the patient's eye with the healon.The procedure was completed successfully.Neither the vial or the foreign material are available for inspection.The same issue was reported on two (2) vials, therefore 2 mdrs will be submitted.This is the first of 2 reports.
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