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	Vitrectomy (2643); No Code Available (3191)
Date of Event	09/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not applicable, as the lens was not implanted; therefore, not explanted.(b)(4).Device evaluation the lens was not returned to the manufacturer for evaluation as the customer indicated that it was lost.Visual inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no associated nonconformity reports or deviations.The lenses were released according to specifications.The complaint history search revealed no other complaints for this production order number has been received.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 abbott medical optics has been submitted.
Event or Problem Description
It was reported that a z9002 29.5 diopter intraocular lens (iol) was removed from a patient's right eye, due to not having enough capsule support.The incision was enlarged, vitrectomy and sutures were required.There were no post-op issues.Product was lost and will not be returned.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6056291
• Report Number: 2648035-2016-01653
• Device Sequence Number: 28777
• Product Code: HQL
• UDI-Device Identifier: 05050474530881
• UDI-Public: (01)05050474530881(17)200227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 10/25/2016

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: 02/27/2020
• Device Model Number: Z9002
• Device Catalogue Number: Z900200295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2016
• Initial Report FDA Received Date: 10/26/2016
• 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
• Patient Age: 76 YR