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
There is no indication at the time of this report that the lens has been explanted.(b)(4).Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site for evaluation.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records were reviewed.During the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Based on review, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
On (b)(6) 2016, it was reported that a patient is extremely unhappy with the results and complained about halos after implantation of a zkb00 intraocular lens (iol).Reportedly, physician stated that the patient is 20/20, and he couldn't ask for a better result clinically.Additional information received on (b)(6) 2016 stating that as of last week, patient is still 20/20 in both eyes, but still very frustrated with glare in both eyes.This report represents the lens implanted in patient's left eye.A separate report is being filed for the lens implanted in patient's right eye.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6119111
• Report Number: 9614546-2016-00618
• Device Sequence Number: 16244983
• Product Code: MFK
• UDI-Device Identifier: 05050474560024
• UDI-Public: (01)05050474560024(17)190203
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2016

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: 02/03/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2016
• Initial Report FDA Received Date: 11/21/2016
• 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: Other