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)
Date of Event	05/23/2017
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 reported that a zkb00 20.5 diopter intraocular lens (iol) was explanted from a male patient's left eye due to patient not being to tolerate halos and glare.The lens was replaced with a z9002 iol with a lower diopter size (19.5).The explanted lens from the left is noted as not being returned.The physician also stated that this was the second explantation for this patient.The lens in the right eye was also explanted on (b)(6) 2017.This report will capture the lens explanted from the patient''s left eye and a separate report will be filed for the lens explanted from the right eye.No further information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review of the complaint folder it was identified that the investigation result for this event was inadvertently reported under the supplemental report with mfr 9614546-2017-00540 when it should have been under 9614546-2017-00541.The following section has been updated accordingly.Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the customer's 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: 6648939
• Report Number: 9614546-2017-00541
• Device Sequence Number: 10986093
• Product Code: MFK
• UDI-Device Identifier: 05050474560093
• UDI-Public: (01)05050474560093(17)200225
• 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 Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

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: 02/25/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 08/25/2017
• 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