Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Lot number - unknown.Unique identifier (udi) number - unknown.Medical product - whitestar signature pro ((b)(4)), jnj phaco tip (lot 5185577), healon pro (lot uj31556).Implant date: opo71 tubing is not an implantable device.Explant date: opo71 tubing is not an implantable device; therefore, not explanted.Telephone number: (b)(6).The opo71 tubing has not being received.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this equipment 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.
|
Additional information: through follow up it was learnt that the fragments were send by the customer to an independent laboratory.The fragments have been confirmed to be bone fragments and were not part of any johnson & johnson device.It appears that there was some cross contamination in the sterilizing room as orthopedic instruments are sterilized there as well.No further information was provided.Type of investigation, investigation findings and investigation conclusions codes added as a result of the new information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|