MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZKB00
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zkb00 intraocular lens (iol) was explanted due to lens poor performance.Patient was dissatisfied with the outcome.Through follow up it was learned that the physician had planned to explant the lens in december, however the explant did not occur until (b)(6) 2017.The lens was replaced with a monofocal lens without incident.There was no incision enlargement or vitrectomy required.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 03/08/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection with the unaided eye shows the product is damaged, most probably to make explant possible.The product was also inspected using a 12x magnification, and it can be seen that the product is damaged on the optic edge.The complaint cannot be confirmed.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.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 intraocular lenses.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: 6239927
• Report Number: 9614546-2017-00021
• Device Sequence Number: 443597
• Product Code: MFK
• UDI-Device Identifier: 05050474560192
• UDI-Public: (01)05050474560192(17)191006
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/06/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 04/26/2017
• 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