MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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 non-healthcare professional reported that following an intraocular lens (iol) implant procedure, when the patch was removed, the patient could only see a white background much like an illuminated computer screen or etched glass and floaters in the eye.The patient later followed up with his doctor and he attributed it to his rk (radial keratotomy) surgery performed.Over time, the whiteness faded, but the patient can¿t focus anything at distance.Doctor arranged for a magnetic resonance imaging (mri) but nothing conclusive was found.The patient was referred to a retinologist, at his visit told him that the surgeon thought the lens was wrong for there wasn't enough contrast and there was damage to the lining of the cornea.The surgeon now recommended removing the company¿s lens and implanting an unspecified monofocal lens and depending on the outcome a partial cornea replacement.All have concluded there was no macular degeneration and glaucoma.Eye pressures normal.Additionally, the patient reported having astigmatism.The surgeon noted that the cells on the inside of the cornea are only 75% and it may need a partial cornea transplant.Hence the lens was explanted and replaced with another non-company lens in a secondary procedure.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 23496449
• Report Number: 9612169-2025-02233
• Device Sequence Number: 9048788
• Product Code: MJP
• UDI-Device Identifier: 00380652456364
• UDI-Public: (01)00380652456364(17)260118(11)220120(10)25333478
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2026
• Device Model Number: CCWET6
• Device Lot Number: 25333478
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/07/2025
• Date Device Manufactured: 01/20/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Male