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

Model Number	CC60WF
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 during the intraocular lens (iol) implant procedure, observed defective lens.Additional information has been requested.
Event or Problem Description
Additional information has been received that the cartridge was cracked, and the lens would not advance during loading/priming of lens.There was no patient contact.In surgeon¿s opinion the event caused by cracked cartridge.
Additional Manufacturer Narrative
Additional information provided in b.2., b.5.And h.11.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a (device malfunction / incident).No further reports required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 23815736
• Report Number: 1119421-2025-03156
• Device Sequence Number: 9286067
• Product Code: HQL
• UDI-Device Identifier: 00380652396905
• UDI-Public: (01)00380652396905(17)290809(11)250811(10)16083524
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: CC60WF
• Device Lot Number: 16083524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/09/2026
• Date Device Manufactured: 08/11/2025
• 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: MONARCH II FORCEPS.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.; PROVISC.
• Patient Sex: Unknown