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

Model Number	CCWET4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 physician reported that, after intraocular lens implantation surgery, the patient's post operative vision was 20/60 and the lens had rotated to 27 degree axis with refraction -1.76 +3.00 x95.The surgeon had used 10 diopter lens at 90 degrees initially.So, the doctor ran astigmatism fix and it said to rotate the lens back to 80 degrees so the patient would end up about -0.50 +0.50 x80.The patient had an appointment for his second eye on (b)(6) and the doctor was thinking to rotate the lens on the same day.Additional information was received stating that, the lens got rotated after surgery which was larger than normal al.The doctor then re-rotated the lens and the patient was doing better.Additional information was received stating that, the diagnosis of the harm was blurry uncorrected vision with more astigmatism, the patient's issue was not resolved, the lens was rotated to the correct axis but then it re rotated out of the position again by 1 week after the surgery.The lens which rotated out of the position for the second time was not fixed.
Additional Manufacturer Narrative
Additional information was provided in h.11.The product was not returned for analysis.Information was provided that lens rotated after surgery.The patient had a larger than normal axial length.The lens had to be repositioned.The root cause for the reported complaint could not be determined.No sample was returned for analysis.The patient had a larger than normal axial length, this may have contributed to the intra ocular lens (iol) rotation.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: 22204465
• Report Number: 9612169-2025-01232
• Device Sequence Number: 17833851
• Product Code: MJP
• UDI-Device Identifier: 00380652486101
• UDI-Public: (01)00380652486101(17)260830(11)220901(10)25487932
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2026
• Device Model Number: CCWET4
• Device Lot Number: 25487932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 09/01/2022
• 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: HEALON; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; ORA SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male