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

Model Number	CNWET3
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/07/2026
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported that, following intraocular lens implantation surgery, the patient experienced poor midrange and near vision.Hence, the lens was explanted and replaced with another atiol (advanced technology intraocular lens) in a secondary procedure.The clinical reason for explantation was a damaged lens haptic, which did not remain centered.Additional information has been requested and received, stating that the surgeon who performed the surgery noted lens decentration and a complaint of poor near vision on the first post-operative day.Damage to the lens haptic was not noticed until intraoperatively during the iol exchange, as the lens optic-haptic junction was not visible on dilated examination following the first surgery due to the decentration.In the surgeon's opinion, the lens implant likely became damaged during insertion using a company injector and cartridge.There was no further impact on the patient, and the surgeon's prognosis was excellent.

• 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: 25769456
• Report Number: 9612169-2026-01558
• Device Sequence Number: 10471692
• Product Code: MJP
• UDI-Device Identifier: 00380652466394
• UDI-Public: (01)00380652466394(17)270130(11)230201(10)25580332
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWET3
• Device Lot Number: 25580332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 02/01/2023
• 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: ABERROMETER.; CLAREON VIVITY TORIC EXTENDED IOL.; MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.; PROVISC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female