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 Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the intraocular lens remains implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) will be explanted soon due to the patient "just has different vision demands." no further information has been provided.
Additional Manufacturer Narrative
Additional information: further information was provided.It was stated that the planned explant of the lens has not been done yet.The patient is pending a last recheck by the doctor and once complete, the explant surgery will be scheduled then.No further information was provided.Device evaluation: to date, the lens remains implanted; therefore, is not available for investigation.The customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.The documentation shows that the production order was manufactured according to specifications.A search of complaints revealed that no similar complaints were received for this production order number.Labeling review: a review of the directions for use (dfu) were performed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.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: 5951192
• Report Number: 9614546-2016-00459
• Device Sequence Number: 10921691
• Product Code: MFK
• UDI-Device Identifier: 05050474560154
• UDI-Public: (01)05050474560154(17)190218
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2017

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: 02/18/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 02/13/2017
• 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: Other