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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/not provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A patient contacted amo to report that her near vision was 20/100 following implant of an intraocular lens, iol.Patient stated she is planning on having the lens explanted.Follow up with the surgeon's office was performed.It was confirmed that the lens was explanted from a female patient's right eye on (b)(6) 2016.The lens was replaced with a model zlb00 lens with the same diopter size.No further information was provided.
Additional Manufacturer Narrative
On the initial report incorrectly indicated that the lens was explanted from the patient's right eye.Through follow-up it learned that the lens was explanted from the patient's left eye.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.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 SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6250927
• Report Number: 9614546-2017-00030
• Device Sequence Number: 828400
• Product Code: POE
• UDI-Device Identifier: 05050474605008
• UDI-Public: (01)05050474605008(17)211007
• Combination Product (Y/N): N
• 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,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,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?: No
• Operator of Device: Physician
• Device Expiration Date: 10/07/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/03/2017; 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