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	Visual Disturbances (2140); 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), 21.0 diopter was explanted in the right eye (od) of a female patient because of poor vision.No further information was provided.
Additional Manufacturer Narrative
Additional info: new information received reports that the lens in the patient's right eye has not been explanted as originally reported in the initial mdr.Information provided notes lens is planned for explant; but no date is scheduled.If explanted; give date: na (not applicable) to date, the lens remains implanted.(update).(b)(4).Device evaluation: to date, the lens remains implanted and therefore, was not returned.An investigation was not possible and the customer's reported event could not be confirmed.Manufacturing record review: the manufacturing records were reviewed.There were no non conformances with respect to the manufacturing process.There were no associated nonconformity reports or deviations.The product was manufactured according to specification.The in-line optical inspection data shows the lens is within power specification.A search on complaints revealed that no other complaints for this order number were received to date.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the lens.Based on the results of the investigation, no product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received reported that an explant was performed on (b)(6) 2017.There was no incision enlargement performed and no sutures used.Reportedly, there was no patient injury post-operatively.The explanted lens was disposed of.Based on this information the following fields have been updated accordingly.Explant date: (b)(6) 2017.(b)(4).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
• MDR Report Key: 6019301
• Report Number: 9614546-2016-00507
• Device Sequence Number: 16623708
• Product Code: MFK
• UDI-Device Identifier: 05050474560109
• UDI-Public: (01)05050474560109(17)190324
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2018

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: 03/24/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: Not provided; 12/15/2017
• Initial Report FDA Received Date: 10/11/2016
• Supplement Report FDA Received Date: 11/11/2016; 01/11/2018
• 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