MAUDE Adverse Event Report: ALCON RESEARCH, LLC ACRYSOF ASPHERIC UV ABSORBING IOL; INTRAOCULAR LENS

Model Number SA60WF

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/18/2022

Event Type  malfunction  

Event 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.

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 16311961
• MDR Text Key: 309025150
• Report Number: MW5114727
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/02/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.220
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALPHAGAN; ARED VITAMIN; GINKO BOLBA; LORSORTAN; MULTI-VITAMIN; RESTAYSIS; TUMERIC; VITAMIN C
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White, American Indian Or Alaskan Native