MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon Vivity Toric Extended Vision UV Absorbing IOL; Lens, Intraocular, Toric Optics

Model Number	CCWET4
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced poor vision.Clinical reason was decrease in best corrected visual acuity.The iol was was exchanged for company lens 1 month 2 weeks 4 days following the initial implant procedure.There was scuff on lens.There was no patient harm.Additional information recieved and file was updated accordingly.There are two medical device reports associated with this complaint.This report is for right eye.
Additional Manufacturer Narrative
A product was not returned for analysis.A batch record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the medical device file were met.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.

• 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 ; +1(800)757-9780
• MDR Report Key: 50233333
• Report Number: 1119421-2026-01696
• Device Sequence Number: 13398385
• Product Code: MJP
• UDI-Device Identifier: 00380652455732
• UDI-Public: (01)00380652455732(17)300316(11)260318(10)16220150
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/13/2026

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: CCWET4
• Device Lot Number: 16220150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 03/18/2026
• 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: CLAREON MONARCH IV Injector; MONARCH III IOL Cartridge D; PROVISC OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female