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); No Code Available (3191)
Date of Event	11/23/2016
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 during implantation of a z9002 23.5 diopter intraocular lens (iol) the patient's capsule broke.The lens was inserted and the lens had to be cut in half to be removed as there was not enough zonules to support the lens.Incision enlargement and one suture was required.Through follow-up it was clarified that the patient went home aphakic, without a lens being implanted and was referred to a retinal specialist.There was no issue the amo cartridge or lens.The issue was with the patient's anatomy.Patients had weak zonules and as a result the capsule broke.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 01/14/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Device inspection was performed and the lens was received in two pieces as described on the initial report (cut related to removal).Residues of viscoelastics were observed on the lens surface.The lens was also observed with both haptics damaged (distorted).There was no allegation against the lens quality, therefore no issue could not be verified.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: 6183465
• Report Number: 2648035-2016-02061
• Device Sequence Number: 10785421
• Product Code: HQL
• UDI-Device Identifier: 05050474530768
• UDI-Public: (01)05050474530768(17)210413
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/22/2017

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: 04/13/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 02/22/2017
• 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