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	09/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the explanted lens was discarded by the surgery center and therefore product evaluation could not be performed.The reported complaint was not verified.Manufacturing record review: a review of the manufacturing records was conducted.Results revealed the device was manufactured according to specifications.There are no associated nonconformity reports or deviations.The product met manufacturing release criteria.A search on complaints related to the production order (po) number was conducted.The search revealed that no other complaints for this order number were received to date.As a result of the investigation there is no indication of a product quality deficiency and the reported issue was not verified.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zlb00 16.5 diopter intraocular lens (iol) was explanted from a female patient's left eye due to the patient experiencing a waxy vision.There was no incision enlargement and vitrectomy required.Lens was replaced with a non-amo device.The explanted lens was scrapped.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6052964
• Report Number: 9614546-2016-00545
• Device Sequence Number: 16603852
• Product Code: MFK
• UDI-Device Identifier: 05050474560604
• UDI-Public: (01)05050474560604(17)181125
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2016

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: 11/25/2018
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/25/2016
• 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: 80 YR