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 Code	No Code Available (3191)
Date of Event	05/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: complaint device was not returned for evaluation as it was discarded.  the manufacturing production order (po) was evaluated and the devices were manufactured within specifications.The units were released according to specification.There is no related deviation or non-conformity report for this complaint.During manufacturing process, all lenses are inspected under 10x microscope magnification and defective devices are rejected.  a review of the complaints related to the production order was performed and the results revealed no other complaints for this order number.A historical complaint data review was performed and results did not identify any product deficiency.  the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.  based on the results of the investigation there is no indication of a product malfunction or product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
After implantation of a z9002 intraocular lens (iol) in patient's right eye, she was diagnosed with myopia.Lens was explanted and replaced with another same model lens.No incision enlargement, sutures or other patient injury.The explanted lens was discarded.No further information was provided.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5902336
• Report Number: 2648035-2016-01328
• Device Sequence Number: 25774
• Product Code: HQL
• UDI-Device Identifier: 05050474530669
• UDI-Public: (01)05050474530669(17)200203
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2016

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: 02/03/2020
• Device Model Number: Z9002
• Device Catalogue Number: Z900200185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2016
• Initial Report FDA Received Date: 08/24/2016
• 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