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 Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	11/10/2016
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 explanted as the patient did not have quality vision with this lens.Improper fit for the patient was also reported.There was no incision enlargement, no patient injury, and no sutures were required.The lens was replaced with another lens, a different model, a zcb00 +18.0 diopter monofocal lens.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 03/08/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the lens was cut in pieces, most probably to make the explant possible.Considering the condition of the lens additional analysis was not possible.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 similar complaints for this order number have been received.As a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics 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: 6367328
• Report Number: 9614546-2017-00152
• Device Sequence Number: 634674
• Product Code: MFK
• UDI-Device Identifier: 05050474560635
• UDI-Public: (01)05050474560635(17)191007
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 05/12/2017

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: 10/07/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 05/12/2017
• 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: 57 YR