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

Model Number	ZKB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/31/2016
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 from a patient's right eye due to a mechanical complication of the iol, detail of mechanical complication was not provided.At explant there was no incision enlargement, vitrectomy or sutures required.The zkb00 iol was replaced with a non-amo lens.
Additional Manufacturer Narrative
Additional information: through follow up it was learned that the patient's vision was improving.However, no further information or clarification could be obtained with regards to their reported mechanical complication issue.Device evaluation the device was returned to the manufacturer.Visual inspection of the return sample shows the lens is cut in pieces, most probably to make explant possible.The complaint cannot be confirmed.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non conformances with respect to the manufacturing process.There are no associated nonconformity reports or deviations.A search on complaints revealed no other complaints were received for this order number to date.Based on the investigation results there is no indication of 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: 5978976
• Report Number: 9614546-2016-00477
• Device Sequence Number: 1625956
• Product Code: MFK
• UDI-Device Identifier: 05050474560116
• UDI-Public: (01)05050474560116(17)200222
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2016

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: 02/22/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement Report FDA Received Date: 11/18/2016
• 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: Required Intervention
• Patient Age: 49 YR