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	Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.(b)(4).Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site as it remains implanted.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zkb00 22.0 diopter intraocular lens (iol) was implanted in the right eye (od) on (b)(6) 2016.Reportedly, the patient experienced severe glare and halos.The patient''s visual acuity was 20/20 and j1+.The doctor recommended a yttrium-aluminum garnet (yag) capsulotomy procedure in both eyes, but explained that if it were performed, a lens exchange would not be possible.No additional information was provided.The patient had bilateral lenses implanted.This report will capture the lens implanted in the patient''s right eye.A separate report will be filed for the left eye.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6967602
• Report Number: 9614546-2017-01006
• Device Sequence Number: 16440005
• Product Code: MFK
• UDI-Device Identifier: 05050474560123
• UDI-Public: (01)05050474560123(17)200315
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2017

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: 03/15/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/21/2017
• 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