MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLAREON; INTRAOCULAR LENS

Model Number	CC60WF
Medical Device Problem Codes	Nonstandard Device (1420); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Blurred Vision (2137); Diplopia/Double Vision (4802); Eye Irritation (4803)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter stated he had cataract surgery with two different intra-ocular lenses (iol).On (b)(6) 2024 left eye.On (b)(6) 2024 right eye.The left eye was done first and came out "ok".Pt said " i went to the store later that day with my brother and everything started turning gray.My vision came back and it was 20/20 everything was fine.A month later, i had difficulties seeing, writing and even driving.It looks like i was seeing double cars.I cannot see.My vision is 20/50, and i am having eyes irritation i did my research and found that the doctor used old inventory in my eye.He used acrysof instead of clareon lenses.This is proven by the model and lot numbers.I have been to other professionals who told me the same thing.I have contacted the surgeon office many times but they kept telling me to wait six weeks.It is going on a year and this is not normal." patient reported there was a recall in 2020 on the lot number 15768166 that went into the left eye.The issue involve a preloaded delivery system called ultrasert preloaded delivery system.The company discover that some lenses were mislabel.Potential risk include: implant with wrong prower, refractive error, leading to blur or decrease vision.It is import to know that this was a class two device recall meaning exposure to the product may cause reversable adverse health consequences.Hecc: 2137, 4802, 4803.Dpc: 4001, 1420.Reference report mw5176220.

• Brand Name: CLAREON
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 23083964
• Report Number: MW5176219
• Device Sequence Number: 18234797
• Product Code: HQL
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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
• Device Model Number: CC60WF
• Device Lot Number: 15768166
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Unknown
• Patient Weight: 86 KG