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 Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was initially reported that a that a zkb00 14.0 diopter intraocular lens was explanted from a female patient¿s eye due to the patient needed a victrectomy.Through follow up additional information was provided.It was noted there was a mechanical issue with the lens.The surgeon brought the patient back to the operating room two (2) weeks post implant to explant the lens and replace it with a non amo anterior chamber lens.There was no capsule tear or incision enlargement required to remove the lens.Clarification was requested to specify what kind of mechanical issue of the lens was noted.The response was that the patient just needed a different power lens because of the vitrectomy performed after the lens was implanted.Nothing technically wrong with the lens.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 05/29/2017.Device returned to manufacturer? yes.Device evaluation: the device was returned to the manufacturer.Visual inspection with the unaided eye shows the product is damaged and incomplete, 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: 6562151
• Report Number: 9614546-2017-00401
• Device Sequence Number: 19029794
• Product Code: MFK
• UDI-Device Identifier: 05050474559967
• UDI-Public: (01)05050474559967(17)200831
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 07/27/2017

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: 08/31/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 07/28/2017
• 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: 72 YR