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	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: if explanted, give date: not applicable as the lens remains implanted.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
A patient reported her vision is okay, not what she expected, and it feels as though there is a film over her eyes, especially the left eye.The patient underwent an yttrium aluminium garnet (yag) procedure for the left eye and not the right eye.Her physician told her that she still has a slight astigmatism.The patient is frustrated as her vision has declined and fluctuates mostly on the less than acceptable of 20/40.Additionally, she reported not feeling balanced which affects standing and walking, various lights affect my vision and i have to keep low lighting on.Dampness seems to affect my eyes.I seem to be able to use my computer and read okay.Trying to read digital numbers such as those on a tv or radio is not clear and adjusting to read them is difficult.I have also had recent ocular migraines.I have visited two retina specialists who did see that the gel has not settled in my eyes.I am trying to find out what part the gel plays, and/if there is another reason for my most troublesome left eye.This report will capture the zkb00 22.0 diopter intraocular lens (iol) implanted in the left eye and a separate report will be filed for the right eye.No further information was provided.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue could not be verified.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.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.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: 6574212
• Report Number: 9614546-2017-00435
• Device Sequence Number: 16338875
• Product Code: MFK
• UDI-Device Identifier: 05050474560123
• UDI-Public: (01)05050474560123(17)181107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

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: 11/07/2018
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 06/23/2017
• 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: Other