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	07/29/2016
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 a zlb00 29.5 diopter intraocular lens (iol) was explanted in a secondary procedure.There was an incision enlargement and the lens was replaced with another zlb00 lens but a lower diopter (24.0).
Additional Manufacturer Narrative
On the initial mdr usage of device was indicate as yes, this was an error the correct response should have been no as this product is not a single use device that was reprocessed and reused on a patient.The correction has been made on this submission.Additional information: device available for evaluation ¿ yes, returned to manufacturer on 09/16/2016.: device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection of the return sample shows the lens is cut in half, most probably to make explant possible.The complaint could not be confirmed.During the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.A search on complaints revealed no other complaints were received for this order number to date.Based on the investigation results there is no indication of 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: 5912676
• Report Number: 9614546-2016-00424
• Device Sequence Number: 392427
• Product Code: MFK
• UDI-Device Identifier: 05050474560864
• UDI-Public: (01)05050474560864(17)190122
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/09/2016

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: Health Professional
• Device Expiration Date: 01/22/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2016
• Supplement Report FDA Received Date: 11/09/2016
• 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: 58 YR