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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC ACRYSOF ASPHERIC UV ABSORBING IOL; INTRAOCULAR LENS
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ALCON RESEARCH, LLC ACRYSOF ASPHERIC UV ABSORBING IOL; INTRAOCULAR LENS Back to Search Results
Model Number SA60WF
Health Effect - Clinical Codes Failure of Implant (1924); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 01/18/2022
Type of Reportable Event Malfunction
Event or Problem Description
I had cataract surgery in both eyes.The same implant was used in both eyes.Every since, i have had new glare problems, starburst patterns around lights at night, and ghosting, making it hard to read.I have complained to the surgeon's office, only to be referred to a retinal specialist.That proved to be a waste of time as they found nothing wrong with my retina.The doctor did say he saw a reflection in my cornea which is something new.All attempts, even letters, have been ignored with no contact from the surgeon.I think these problems are a direct result of the implant used.
 
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Brand Name
ACRYSOF ASPHERIC UV ABSORBING IOL
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC
MDR Report Key16311961
Report NumberMW5114727
Device Sequence Number5685314
Product Code HQL
UDI-Device Identifier00380652332705
UDI-Public00380652332705
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 02/02/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberSA60WF
Device Catalogue NumberSA60WF.220
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/06/2023
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ALPHAGAN; ARED VITAMIN; GINKO BOLBA; LORSORTAN; MULTI-VITAMIN; RESTAYSIS; TUMERIC; VITAMIN C
Outcome Attributed to Adverse Event Other;
Patient Age54 YR
Patient SexFemale
Patient Weight54 KG
Patient EthnicityNon Hispanic
Patient RaceWhite, American Indian Or Alaskan Native
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