MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/16/2016
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 lens was explanted and exchanged with a non amo lens.The reason for explant was not provided.There was no incision enlargement or sutures required.There was no patient injury reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 01/25/2017.Device returned to manufacturer ¿ yes.Through follow-up it was clarified that the lens was explanted for a subsequent retinal surgery.Initially it was reported that the lens was replaced with a non-amo iol, however the follow-up confirmed that the lens was replaced with a za9003 iol after the retinal procedure.The retina procedure had nothing to do with the iol involved.Device evaluation: the device was returned to the manufacturer.Visual inspection of the device with an unaided eye shows the product is cut in half, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.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 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6248510
• Report Number: 9614546-2017-00029
• Device Sequence Number: 10997373
• Product Code: MFK
• UDI-Device Identifier: 05050474560710
• UDI-Public: (01)05050474560710(17)191116
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2017

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: 11/16/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/15/2017
• 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: 80 YR