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

Model Number	SY60WF
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that, during an intraocular lens (iol) implantation procedure, the iol was observed to be brittle and kinked in the cartridge when advancement was attempted during loading, with no patient contact.The event was attributed to rupture of the leading haptic, as the iol did not appear to fold correctly.It was further reported that the replacement iol also appeared unusually brittle; however, it was implanted without incident.Additional information was requested but was not available at the time of this report.
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 Hydrophobic Acrylic 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: 50774465
• Report Number: 1119421-2026-01877
• Device Sequence Number: 13117798
• Product Code: HQL
• UDI-Device Identifier: 00380652251594
• UDI-Public: (01)00380652251594(17)290527(11)250529(10)16044854
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/15/2026

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: SY60WF
• Device Catalogue Number: SY60WF.255
• Device Lot Number: 16044854
• 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: 05/29/2025
• 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: CLAREON MONARCH IV IOL Delivery System, Injector; DISCOVISC Ophthalmic ViscoSurgical Device; MONARCH II Loading Forceps; MONARCH III IOL Delivery System, Cartridge D
• Patient Sex: Unknown