MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon Aspheric UV Absorbing IOL; Intraocular Lens

Model Number	CC60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during the intraocular lens (iol) implant procedure lens haptic found to be torn.The lens was implanted and removed on the same day.Additional information received and stated that, the originally scheduled procedure was completed on the same day.As per the surgeon contributory cause was possible issue with the lens cartridge; during injection, the iol trailing haptic stuck on the plunger.When the doctor attempted to free it with his second instrument, the trailing haptic tore off.The tech noted that the cartridge was cracked and indicated that the trailing haptic might have been stuck between the plunger and cartridge.There was no impact to the patient as the doctor was able to remove the damaged iol immediately without issue.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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 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 ; +1(800)757-9780
• MDR Report Key: 50813199
• Report Number: 1119421-2026-01894
• Device Sequence Number: 13423929
• Product Code: HQL
• UDI-Device Identifier: 00380652396899
• UDI-Public: (01)00380652396899(17)300304(11)260306(10)16209734
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 09/17/2026

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: CC60WF
• Device Lot Number: 16209734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 03/06/2026
• 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: MONARCH II Loading Forceps.; MONARCH III IOL Delivery System, Cartridge D.; MONARCH III IOL Delivery System, Injector.; PROVISC Ophthalmic ViscoSurgical Device.
• Patient Age: 69 YR
• Patient Sex: Male