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

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a zxt375 16.0 diopter intraocular lens (iol) was explanted from a male patient's left eye due to a refractive miss.The lens was replaced with a zxt150 iol with a higher diopter size.The customer stated that the exchange was not due to a faulty lens.No further information was provided.
Additional Manufacturer Narrative
Additional information was received clarifying that the customer provided incorrect information regarding the implant and explant date.Customer clarified that the zxt375 16.0 diopter iol was explanted on (b)(6) 2017, and the implant date is unknown as it was not provided.The following sections have been updated accordingly: date of event: (b)(6) 2017.If implanted; give date: unknown, was not provided.If explanted, give date: (b)(6) 2017.Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue 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 device.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: 6565168
• Report Number: 9614546-2017-00411
• Device Sequence Number: 133531
• Product Code: POE
• UDI-Device Identifier: 05050474606890
• UDI-Public: (01)05050474606890(17)210930
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2017

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: 09/30/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 06/12/2017
• 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
• Patient Age: 57 YR