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

Model Number	CNW0T4
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A facility representative reported that during surgery, they noted the damaged lens.Additional information has been requested and received stating that the initial lens was loaded into the injector by my scrub technician.As the lens was coming out of the injector, it appeared the lens was trying to "flip".As a result, the lens injector was removed from the eye.As the lens was injected out of the injector to be reloaded for implantation, the trailing haptic disconnected from the optic.A backup lens was used at that time.After inserting the lens into the eye, the trailing haptic became "stuck" in the lens injector.Forceps were used to gently remove the trailing haptic from the injector, but the haptic was broken approximately half way to its connection on the optic.Procedure was completed on the same day.Issue noted with the initial lens during priming.Surgeon was uncertain what caused the event, if faulty lens or error in loading.Both lenses felt "fragile" compared to previous lenses used and had previously had haptics get "stuck" in the injector and had always been able to gently remove the haptic from the injector without difficulty.Surgeons prognosis was noted to be good.Lens was able to be removed and replaced with a non-toric lens.

• Brand Name: CLAREON TORIC 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: 25255096
• Report Number: 1119421-2026-01102
• Device Sequence Number: 10545235
• Product Code: MJP
• UDI-Device Identifier: 00380652402347
• UDI-Public: (01)00380652402347(17)291117(11)251119(10)16152815
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNW0T4
• Device Lot Number: 16152815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 05/22/2026; 06/22/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/17/2026; 07/16/2026
• Date Device Manufactured: 11/19/2025
• 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: UNSPECIFIED FORCEPS.
• Patient Sex: Unknown