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

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was removed in the initial procedure (b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was removed during the initial surgery.During implant of the lens, the patient had a tear in his right eye (capsule) which spread and required the doctor to perform a vitrectomy.No incision enlargement was required.The patient was sent home aphakic.The patient returned at a later date and a successful lens implant was performed.The patient was reported as fine.There was no quality issue with the lens.No further information was provided.
Additional Manufacturer Narrative
(b)(4).Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for investigation.Visual inspection at 10x microscope magnification was performed.The lens optic body edge is smooth.The lens was observed with one haptic distorted/bent.The complaint issue could not be verified.Manufacturing record review: a review of the manufacturing records was performed.There were no discrepancies found during the review.The documentation shows that the production order was manufactured according to specifications.There were no associated deviation or non-conformity reports found in the review related to the complaint.The units were released according specification in compliance with the product intended use as required.A search on complaints revealed no other complaints have been received for this production order number.Labeling evaluation: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the lenses.Based on the results of the investigation, no quality product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6309566
• Report Number: 2648035-2017-00224
• Device Sequence Number: 19024619
• Product Code: HQL
• UDI-Device Identifier: 05050474530621
• UDI-Public: (01)05050474530621(17)210302
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2017

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: 03/02/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 03/09/2017
• 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