MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; MONOFOCAL IOLS

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a za9003 intraocular lens (iol) was explanted as the patient could not tolerate the lens.The physician was targeting -1.00 with a 11.50 iol, however got +4.12.There was no incision enlargement or sutures required.There was no patient injury required.The lens was replaced with the same model lens with a different diopter size (19.5).
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 3/9/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed and lens was observed cut in two pieces.Fibers/particles were observed on the lens related to the handling the lens in a non-sterile environment.Residue of viscoelastic solution was observed on lens which indicated that the unit was handled and prepared for surgical use.The lens was also observed with white debris apparently from some material used during the surgery process.The complaint issue reported could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6370927
• Report Number: 2648035-2017-00392
• Device Sequence Number: 13645231
• Product Code: HQL
• UDI-Device Identifier: 05050474528840
• UDI-Public: (01)05050474528840(17)171120
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 11/20/2017
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR