Catalog #: catalog # is unknown as lot number was not provided.Unique identifier (udi#): unknown, as lot number was not provided.Expiration date: unknown, as lot number was not provided.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. device manufacture date: unknown as lot number was not provided.The product is not returning for evaluation.There was no lot number reported for this device; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending, for this device will not be performed.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
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It was reported that healon endocoat cannula was not staying on during the case even with protective guard on.Additional information was received, and it was learnt that this was observed prior to lens insertion.There was no patient injury.No incision enlargement, no vitrectomy and no sutures required.Patient is doing good.No further information provided.
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