MAUDE Adverse Event Report: ALCON LABORATORIES, INC. /ALCON RESEARCH, LLC AXRYSOF IQ PANOPTIX UV IOL (RIGHT EYE); LENS, MULTIFOCAL INTRAOCULAR

Model Number	TFAT00
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
I had a panoptix intraocular lens placed in my right eye on (b)(6) 2021.My vision prior to the surgery was correctable to 20/20.My right eye vision is now blurry and cannot be corrected to 20/20.I have had several follow-up visits with my ophthalmologist and yesterday she said nothing more can be done.Consumers should be notified that a small percentage of recipients of this implant will have worse vision than before the surgery and that it is a permanent result.I was not informed of this.

• Brand Name: AXRYSOF IQ PANOPTIX UV IOL (RIGHT EYE)
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON LABORATORIES, INC. /ALCON RESEARCH, LLC
• MDR Report Key: 16132383
• Report Number: MW5114253
• Device Sequence Number: 3253047
• Product Code: MFK
• UDI-Device Identifier: 00380652429696
• UDI-Public: 00380652429696
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.190
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACCUPRIL 20MG TWICE DAILY
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White