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
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zkb00 12.0 diopter intraocular lens (iol) was implanted in the right eye (od) on (b)(6) 2017.It was later explanted on (b)(6) 2017 due to the patient complaining of halos, glare, and problems driving at night.The lens was replaced with a z9002 12.5 diopter iol.Reportedly, the patient is doing fine post-operatively.No additional information was provided.
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zkb00 12.0 diopter intraocular lens (iol) was implanted in the right eye (od) on (b)(6) 2017.It was later explanted on (b)(6) 2017 due to the patient complaining of halos, glare, and problems driving at night.The lens was replaced with a z9002 12.5 diopter iol.Reportedly, the patient is doing fine post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 10/23/2017.Device returned to manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.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 were 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.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6953435
• Report Number: 9614546-2017-00983
• Device Sequence Number: 13579521
• Product Code: MFK
• UDI-Device Identifier: 05050474559929
• UDI-Public: (01)05050474559929(17)200315
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 12/28/2017

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: ZKB00U0120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 11/13/2017; 12/26/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 12/11/2017; 12/28/2017
• 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