MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon IOL; Intraocular Lens

Model Number	SY60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction

• Brand Name: Clareon IOL
• Common Device Name: Intraocular Lens
• Manufacturer (Section D): Alcon Laboratories Ireland Ltd.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): Alcon Laboratories Ireland Ltd.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50907386
• Report Number: 9612169-2026-02208
• Device Sequence Number: 12292372
• Product Code: HQL
• UDI-Device Identifier: 00380652251495
• UDI-Public: (01)00380652251495(17)290420(11)250422(10)26020404
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2026

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 Lot Number: 26020404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/26/2026
• Date Device Manufactured: 04/22/2025
• 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
• Patient Sex: Unknown