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

Model Number	CCW0T4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
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).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision with activity of daily living.Clinical reason for explant mechanical complication of intraocular lens.The iol was exchanged for unspecified toric monofocal lens 2 months 5 days following the initial implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
The account indicated the use of qualified associated products.An iol exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Information was provided that, in the surgeon's opinion, the product did not cause or contribute to the event.Based on the information provided, the event does not appear to be related to the product.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Additional information was provided that the company (2.25cyl), 21.0 diopter lens was replaced with a company (2.25cyl), 18.0 diopter lens.It was reported that the patient had prior myopic lasik surgery.The account indicated the product was not available to evaluate.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating as per surgeon opinion iol caused the patient harm poor quality of vision.The iol was exchanged from toric 22.0 diopter company lens to toric same model 18.0 diopter company lens 2 months 5 days following the initial implant procedure.Patient issues were resolved, and the surgeon prognosis was excellent.

• Brand Name: CLAREON TORIC UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21191325
• Report Number: 1119421-2025-00199
• Device Sequence Number: 15649923
• Product Code: MJP
• UDI-Device Identifier: 00380652432917
• UDI-Public: (01)00380652432917(17)261206(11)221208(10)15546589
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CCW0T4
• Device Lot Number: 15546589
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 03/04/2025
• Date Device Manufactured: 12/08/2022
• 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: BARRETT UNIVERSAL FORMULA; CLAREON TORIC UV ABSORBING IOL; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; ORA SYSTEM WITH VERIFEYE MESSAGING; ORA SYSTEM WITH VERIFEYE MESSAGING, CART; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown