MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; TORIC IOLS

Model Number	ZCT525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	09/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from the patient's left eye due to visual issues where the visual acuity was 20/70 post-op with glare 20/400 and -1.0 + 1.75 x 160.Prior to the initial implant, it was -3.75 + 3.00 x 101.Lens was explanted from the patient's left eye.There was no incision enlargement, vitrectomy, or sutures required and no patient injury was reported.The lens was replaced in a secondary surgery.No further information was provided.
Additional Manufacturer Narrative
The intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.The manufacturing records for the intraocular lens were reviewed.The complaint related test is the cosmetic inspection performed at final inspection.Only units that meet cosmetic inspection criteria are then subject to optical inspection.The in-line optical inspection data shows the lens is within power specification; hence the lens meets the specified cosmetic requirements.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.The directions for use (dfu) were reviewed.The directions for use (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
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6012883
• Report Number: 9614546-2016-00502
• Device Sequence Number: 1612970
• Product Code: HQL
• UDI-Device Identifier: 05050474603509
• UDI-Public: (01)05050474603509(17)201105
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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): 11/18/2016

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: 11/05/2020
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2016
• Supplement Report FDA Received Date: 11/18/2016
• 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: 73 YR