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

Model Number	CCW0T4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Prolapse (2475); Insufficient Information (4580)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following the intraocular lens (iol) implant procedure, patient experienced vitreous prolapse.The lens was explanted with the reason not working and exchanged with atiol lens 4 months following the initial procedure.Clinical reason for explant was mentioned as mechanical complication.Additional information has been received that the lens was rotated from its axis after implantation caused the residual refractive outcome.In the surgeon¿s opinion the product did not cause or contribute the event, it was rotation of the iol after implantation that caused or contributed to the event.The lens was exchanged with company lens of same model.There was no patient impact.The symptoms were resolved.
Additional Manufacturer Narrative
A sample device 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).
Additional Manufacturer Narrative
Corrected information provided in h.6.Correction: on initial mdr the patient code should have been e2401 instead of e2333.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 23372148
• Report Number: 1119421-2025-02773
• Device Sequence Number: 10122186
• Product Code: MJP
• UDI-Device Identifier: 00380652432979
• UDI-Public: (01)00380652432979(17)270823(11)230825(10)15703364
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: CCW0T4
• Device Lot Number: 15703364
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 08/25/2023
• 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 TORIC IOL.; MONARCH II FORCEPS.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown