MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; TORIC 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	12/19/2016
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 zxt 400 to correct the residual astigmatism and hopefully reduce the dysphotopsia.Patient is 20/40 1 day post.This report will capture the zxt iol explanted from the right eye.
Additional Manufacturer Narrative
Corrected data: the initial report incorrectly reported that a zxt 400 was used as the replacement lens.The correct replacement lens was a zct 400 lens.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 03/08/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Visual inspection with the unaided eye shows the lens was not returned.Considering the condition of the return additional analysis is not possible.Manufacturing records were reviewed and the lens was manufactured according to specification.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
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6251889
• Report Number: 9614546-2017-00032
• Device Sequence Number: 938505
• Product Code: HQL
• UDI-Device Identifier: 05050474606418
• UDI-Public: (01)05050474606418(17)210822
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2017

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: 08/22/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• 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: 01/16/2017; 05/02/2017
• 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