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

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Date of Event	01/30/2017
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 patient underwent a bilateral symfony intraocular lens implants.Model zxt 300 were implanted in both eyes.After implantation the patient experienced starbursts in both eyes.Patient did have 1 diopter of residual astigmatism in the right (dominant) eye giving uncorrected visual acuity (ucva) of 20/25 and 20/20 ucva in the left eye.Patient's vision remains the same with minimal residual correction in place (best-corrected).Patient's near vision is good at j2 in both eyes.Patient is happy with her near vision.They explanted the zxt 300 in the right eye and replaced it with a zct 400 to correct the residual astigmatism and hopefully reduce the dysphotopsia.Patient is 20/40 1 day post-op.Additional information was received and it was learnt that they explanted the zxt 300 from the left eye and replaced it with a zct300 +21.5d.No incision enlarged and no vitrectomy was performed.No further information was provided.This report will capture the zxt iol explanted from the left eye.
Additional Manufacturer Narrative
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 no similar complaints were received for this order number to date.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: 6300204
• Report Number: 9614546-2017-00072
• Device Sequence Number: 817520
• Product Code: POE
• UDI-Device Identifier: 05050474606425
• UDI-Public: (01)05050474606425(17)210823
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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: 08/23/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 07/13/2017
• 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: Required Intervention
• Patient Age: 76 YR