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

Model Number	ZCT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vitrectomy (2643)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lens was inserted and removed.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the patient suddenly moved during the implantation of a zxt300 18.5 diopter intraocular lens (iol) in the right eye (od) on (b)(6) 2017.Therefore, the iol was removed and replaced with a non-amo back up lens.There was no incision enlargement or sutures used, but a vitrectomy was performed.Reportedly, there were no patient complications and the patient is doing fine post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 11/21/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection was performed and no anomalies were found.The customer's reported complaint cannot be confirmed.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.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
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6933222
• Report Number: 9614546-2017-00964
• Device Sequence Number: 699125
• Product Code: HQL
• UDI-Device Identifier: 05050474553293
• UDI-Public: (01)05050474553293(17)200405
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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,Followup
• Report Date (Section B): 01/15/2018

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: 04/05/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 01/15/2018
• 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: 49 YR