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	Blurred Vision (2137); No Code Available (3191)
Date of Event	07/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 because the patient could see 20/20 but just was not very happy and is very distressed with blurry vision.A non-amo lens was used as the replacement lens.There was no incision enlargement, vitrectomy or sutures required.Additionally, there was no post-op injury noted.
Additional Manufacturer Narrative
(b)(4).Additional information: device available for evaluation ¿ yes, returned to manufacturer on 09/19/2016.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection of the return sample shows the lens is cut in pieces.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.During the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.A complaint search related to the production order revealed that no other complaints for this order number were received to date.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 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: 5905275
• Report Number: 9614546-2016-00420
• Device Sequence Number: 527675
• Product Code: MFK
• UDI-Device Identifier: 05050474559967
• UDI-Public: (01)05050474559967(17)190810
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2016

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: Health Professional
• Device Expiration Date: 08/10/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0140
• Device Lot Number: 8145041508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2016
• Supplement Report FDA Received Date: 11/09/2016
• 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: 65 YR