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

Model Number	ZLB00
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/13/2016
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 intraocular lens (iol) was explanted in the right eye (od) of a female patient due to doctor had to change diopter power.The iol was replaced with a same model but different diopter 20.0 iol.No further information was provided.
Additional Manufacturer Narrative
Clarification for the first sentence in the initial report should read as, it was reported that a model zlb00 intraocular lens (iol) was explanted from the right eye (od) of a female patient due to doctor having to change the diopter power.(b)(4).Additional information: device available for evaluation: yes.Returned to manufacturer on: 9/16/2016.Device returned to manufacturer: yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection shows the lens is damaged, most probably to make remove and replacement possible.Considering the condition of the lens additional analysis is not possible.The reported complaint cannot be confirmed.Manufacturing records review: a review of the manufacturing records was performed, which indicated that the product was manufactured according to specifications.There were no non conformances with respect to the manufacturing process.There were no associated nonconformity reports or deviations.A search on complaints revealed no other complaints were received for this order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the manufacturing record review of the production order, no product deficiency was identified.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: 5894963
• Report Number: 9614546-2016-00400
• Device Sequence Number: 626010
• Product Code: MFK
• UDI-Device Identifier: 05050474560758
• UDI-Public: (01)05050474560758(17)200324
• 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): 11/10/2016

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: 03/24/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0240
• 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: 07/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2016
• Supplement Report FDA Received Date: 11/10/2016
• 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: 66 YR