MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL; INTRAOCULAR LENS

Model Number	DAT015
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Eye Infections (4466); Diplopia/Double Vision (4802)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, he was extremely disappointed and stated the lens never worked, as he had experienced loss of vision in his right eye (also stated double vision, blurry vision, cloudy vision and infection) since the day of surgery.The consumer reported that, the surgeon referred 2 other doctors and they agreed that his eyesight was terribly distorted and in fact he could not see and glasses would not help.After the surgery he went to 3 other independent doctors who said the operation looks good, but the lens failed.The consumer contacted hospital and their insurance company and came back with a letter on (b)(6) 2025, from an expert that read all medical records and cleared both hospital and surgeon of any wrong doings in the operation.The consumer mentioned at this point he realized loss of vision was caused by company lens and not the doctor error.The consumer also states he experienced difficulties daily and cannot see out of his right eye and want to be compensated, he cannot drive or play golf or do normal things as he usually does.He states company lens has changed his life, and he is disappointed immensely.Additional information has been requested however no further information available.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22566037
• Report Number: 1119421-2025-02007
• Device Sequence Number: 4021875
• Product Code: POE
• UDI-Device Identifier: 00380652424691
• UDI-Public: (01)00380652424691(17)250929(11)200930(10)15103048
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2025
• Device Model Number: DAT015
• Device Catalogue Number: DAT015.230
• Device Lot Number: 15103048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male