MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWET3
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Iritis (1940); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that following the intraocular lens (iol) implant procedure, she experienced decreased vision while driving at night due to glare and also dim vision, had trouble seeing stairs at home in low light.Patient felt vision was good.The left eye was scheduled prior choosing iol and thought unoperated eye could see better.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that the surgeon suspected it was lasik interface.Medicated timolol for one month.On last visit there was a mild iritis (1+ cell), so gave steroids took second opinion with corneal specialist the lens was slightly off the perfect center of the pupil, but still the central circle is inside the pupil.The patient's issues were not resolved.
Additional Manufacturer Narrative
Additional information provided in a.1., a.2., b.2., b.3., b.5., b.6., d.4., d.6.A., d.10., h.6.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information provided in h.6.(fda eval method code).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 RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22773110
• Report Number: 1119421-2025-02230
• Device Sequence Number: 9288845
• Product Code: MJP
• UDI-Device Identifier: 00380652466400
• UDI-Public: (01)00380652466400(17)281116(11)241118(10)15957916
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 10/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWET3
• Device Lot Number: 15957916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/24/2025; 10/01/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/16/2025; 10/23/2025
• Date Device Manufactured: 11/18/2024
• 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,; MONARCH III CARTRIDGE D,; MONARCH III INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female