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

Model Number	CCWET3
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	11/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned taped to a piece of paper in a non-company peel pouch.Blood and solution were dried on the lens.One haptic was broken from the gusset area (not returned).The lens was cleaned with klrp for further evaluation.The optic was torn (possibly cut) from the edge towards the center.When attempting to remove the lens from the adhesive tape, the optic damage was extended.The lens was allowed to dry.Upon drying, the lens appeared clear.A power, cylinder, and optic resolution test were attempted.The lens met specifications for power (17.0 diopter) and cylinder (1.50) for a company 17.0 diopter lens.The optical resolution could not be 100 percent confirmed due to the areas of optic damage on the returned lens.Product history records were reviewed, and the documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.A power, cylinder, and optic resolution test were attempted by engineering technician.The lens met specifications for power (17.0 diopter) and cylinder (1.50) for a company 17.0 diopter lens.The optical resolution could not be 100 percent confirmed due to the areas of optic damage on the returned lens.Information was provided in the file that the company (1.50cyl), 17.0 diopter, (1.5 extended depth of focus) lens was removed and replaced with a non-company toric lens 16.5 diopter.The exchange for a 0.5 lower diopter difference may suggest that the replacement lens was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision, hazy and halos.Clinical reason for explant was mechanical defect iol.The iol was exchanged for another model company lens 3 months 28 days following the initial implant procedure.Additional information has been requested and received stating the lens was replaced with non company lens.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING 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: 21607418
• Report Number: 1119421-2025-00693
• Device Sequence Number: 9275920
• Product Code: MJP
• UDI-Device Identifier: 00380652455220
• UDI-Public: (01)00380652455220(17)260719(11)220721(10)15450325
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2026
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.170
• Device Lot Number: 15450325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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: ARGOS BIOMETER; MONARCH II LOADING FORCEPS; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; ORA SYSTEM WITH VERIFEYE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown