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

Model Number	CCWET3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced poor vision.Clinical reason being mentioned as unable to see.The iol was explanted and exchanged for an unknown atiol (advanced technology intraocular lens) in the secondary implant procedure.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information has been provided in a.2., a3.A.,b.3.,b.5.,b.6.,d.10.,h.3., h.6., and h.11.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested.A questionnaire was received it states that the patient experienced a postoperative refractive surprise resulting in suboptimal visual outcome (magnitude of myopia) and decreased uncorrected visual acuity, but it was not a permanent patient harm so, the it was treated with anticholinergic drug and planned to discontinue.Visual acuity improved following iol exchange was completed with another lens however, the patient was still not achieving the intended refractive target, with residual refractive error present.Patient issues were partially resolved.In the surgeon¿s prognosis anticipates further visual improvement with refractive enhancement.A prk consultation is planned at the next visit to address residual refractive error if needed.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.The reporter stated the company 29.0 iol was replaced with a company 26.0 iol.An iol (intraocular lens) exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product company 29.0 diopter lens was exchanged for an company 26.0 diopter lens.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 24019245
• Report Number: 9612169-2026-00081
• Device Sequence Number: 10545634
• Product Code: MJP
• UDI-Device Identifier: 00380652455466
• UDI-Public: (01)00380652455466(17)260103(11)220105(10)25318870
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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: 01/03/2026
• Device Model Number: CCWET3
• Device Lot Number: 25318870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 03/16/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/05/2026; 04/08/2026
• Date Device Manufactured: 01/05/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL, CARTRIDGE C; MONARCH III IOL, INJECTOR; PROVISC OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female