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 Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	08/01/2025
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 blurry vision.The lens was exchanged for another lens model 02 month 02 days following the initial procedure.Clinical reason for explant was mentioned as residual astigmatism.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 was provided in a.2., a.3.A., b.3., b.5., b.6., b.7., d.10 and e.4.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated, there was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6 and h.11.The product was returned for analysis.The reported complaint cannot be confirmed from the returned sample.Intra ocular lens (iol) received wrapped in a piece of gauze.Solution is dried the iol.The optic is torn/split-cut dividing the iol in two.There are loose fibers on the optic and haptics.The optic edge is chipped.The reporter stated the company iol was replaced with a company iol.The root cause for the reported complaint could not be determined.The exchange from a company iol to a company iol may suggest that the replacement lens was an improved choice for the patient's vision needs.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: 23051768
• Report Number: 9612169-2025-01834
• Device Sequence Number: 18597990
• Product Code: MJP
• UDI-Device Identifier: 00380652455299
• UDI-Public: (01)00380652455299(17)260406(11)220408(10)25362003
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 12/23/2025

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: 04/06/2026
• Device Model Number: CCWET3
• Device Lot Number: 25362003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 12/02/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/08/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; UNSPECIFIED HANDPIECE; UNSPECIFIED IOL LOADING FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female