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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable as the lens was inserted and removed.If explanted, give date: not applicable as the lens was inserted and removed.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that during implantation of z9002 24.0 diopter intraocular lens (iol), the patient's capsule bag was damaged.The lens was removed and replaced with an anterior chamber lens with no other issues with the eye.A vitrectomy and an incision enlargement were required.There was no patient injury reported.There was no product quality issue.
Additional Manufacturer Narrative
Product testing could not be performed because the device was not returned.Therefore, the customer's reported event could not be confirmed.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar 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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6434503
• Report Number: 2648035-2017-00568
• Device Sequence Number: 16222494
• Product Code: HQL
• UDI-Device Identifier: 05050474530775
• UDI-Public: (01)05050474530775(17)210824
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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: 08/24/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 05/10/2017
• 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