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

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 5/7/2017.Device evaluation: the device was returned to the manufacturer.Dvisual inspection with the 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.The device issue could not be confirmed in the returned sample.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that after implantation of a zkb00 18.0 intraocular lens (iol), the patient was not satisfied with the surgery outcome.The lens was exchanged with a zcb00 18.5 diopter iol.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 5/7/2017.Device evaluation: the device was returned to the manufacturer.Dvisual inspection with the 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.The device issue could not be confirmed in the returned sample.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.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: 6342640
• Report Number: 9614546-2017-00115
• Device Sequence Number: 659196
• Product Code: MFK
• UDI-Device Identifier: 05050474560048
• UDI-Public: (01)05050474560048(17)200318
• 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 Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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: 03/18/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 06/26/2017
• 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