MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.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).
Event or Problem Description
A consumer called to report no depth perception or contrast with this lens.She had been unhappy with the lens since the day of surgery.She was told her vision would improve after some healing time, but this had not happened.As a photographer, she cannot work like this.She had fallen twice.She sprained her right wrist the first fall on (b)(6) 2025 and broken her left wrist with the second fall on (b)(6) 2025 needing surgery to repair the wrist.She had discussed this with her surgeon who originally suggested a monofocal lens.Then on a follow up visit, they suggested company vivity lens.She would have an explant and have a monofocal lens implanted.Additional information has been requested and received stating an explanted iol with patient reason as loss of sharp contrast.Clinical reason being changing from company iol to monofocal lens.
Additional Manufacturer Narrative
Additional information has been provided in b.5., h.6., and h.11.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that the explant surgery took longer and was more difficult than expected.Had severe corneal swelling.For the first two weeks patient was basically blind, 20/2600.Was extremely frightened and super despondent.Three weeks and four days post surgery, vision was slowly improving and at 20/50 but had a vaseline type fog in front of the eye.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23952969
• Report Number: 9612169-2026-00016
• Device Sequence Number: 15415225
• Product Code: POE
• UDI-Device Identifier: 00380652405904
• UDI-Public: (01)00380652405904(17)251115(11)211117(10)25307325
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2025
• Device Model Number: CCWET0
• Device Lot Number: 25307325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/03/2026
• Supplement Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 11/17/2021
• 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: Required Intervention; Other
• Patient Sex: Female