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	08/03/2016
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 the intraocular lens (iol) was implanted and then removed within the same procedure due to patient's capsule not supporting the lens.The event was not a product quality issue.It was all due to the condition of the patient's eye.There was no injury post operatively.There was incision enlargement with sutures but no vitrectomy.No further information was provided.
Additional Manufacturer Narrative
The intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed residues of viscoelastics on the lens optic body and loose particles compatibles with handling the lens out of the sterile environment.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 5925033
• Report Number: 2648035-2016-01367
• Device Sequence Number: 18992155
• Product Code: HQL
• UDI-Device Identifier: 05050474530621
• UDI-Public: (01)05050474530621(17)210301
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2016

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: 03/01/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2016
• Supplement Report FDA Received Date: 09/28/2016
• 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: 89 YR