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

Model Number	CNWET4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/25/2025
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 health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced refractive surprise after one day post operative.It had affected the patient ability to perform the daily activities.The lens was exchanged for another company lens model 01 month 20 days following the initial procedure.After iol exchange the event was resolved, there was no permanent impairment or damage and no hospitalization was required.Additional information was received, health care professional suspects an error in the lens calculation.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6 and h.11.The product was not returned for analysis, and the reported complaint cannot be confirmed.The reporter stated the company lens model 4.260 intra ocular lens (iol) was replaced with a company lens model 5.280 iol.An iol 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.The company lens model 4.260 diopter lens was exchanged for an company lens model 5.280 lens.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis.The reported complaint cannot be confirmed from the returned sample.Sample received in a sample container in wet solution.The lens is broken into five pieces: three optic pieces and two broken haptics.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC 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: 23496261
• Report Number: 9612169-2025-02232
• Device Sequence Number: 15696509
• Product Code: MJP
• UDI-Device Identifier: 00380652466912
• UDI-Public: (01)00380652466912(17)290131(11)250202(10)25984724
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

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 Model Number: CNWET4
• Device Lot Number: 25984724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 04/01/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 02/04/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2025
• 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 DELIVERY SYSTEM, CARTRIDGE C.; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female