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

Model Number	CC60WF
Medical Device Problem Codes	Product Quality Problem (1506); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A nonhealth care professional reported that during the intraocular lens (iol) implantation surgery, the scratch and a bubble was noticed inside the lens.Hence the lens was taken out and replaced with a new lens.Additional information was received stating that, the forceps that come with the injector was used for the surgery.The lens was inserted and then it was cut and removed from the patient's eye and it was disposed off.The surgeon stated there was bubbles inside the lens itself and the scratch was not from the forceps or loading.
Additional Manufacturer Narrative
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).

• 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: 50774498
• Report Number: 1119421-2026-01875
• Device Sequence Number: 18513621
• Product Code: HQL
• UDI-Device Identifier: 00380652396806
• UDI-Public: (01)00380652396806(17)300503(11)260505(10)16243066
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/15/2026

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: 16243066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 05/05/2026
• 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: DuoVisc VISCOELASTIC SYSTEM.; MONARCH II Loading Forceps.; MONARCH III Cartridge D.
• Patient Age: 66 YR
• Patient Sex: Unknown