MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Codes	Failure to Deliver (2338); Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report originally filed as 1119421-2026-00452.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that, at the implantation moment, iol passed through the cartridge with a shooting sound.Additional information was requested and received stating that the defect was detected during the surgery.There was patient contact.There was no harm to the patient.The surgery was completed, and after implantation a crease-like mark was noticed on the optical part of the iol.There was no reusing of the product.There was no additional medical manipulation and the patient was stable.After the surgery, the distance vision of the operated eye was 0.9.The patient was discharged with improvement.There are multiple patients reported along with this file.This file is for (b)(6).

• 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 ; 8007579780
• MDR Report Key: 24784872
• Report Number: 9612169-2026-00749
• Device Sequence Number: 9935591
• Product Code: HQL
• UDI-Device Identifier: 00380652251464
• UDI-Public: (01)00380652251464(17)281119(11)241121(10)25948730
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2026

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: 25948730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/04/2026
• Date Device Manufactured: 11/21/2024
• 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: INJECTOR MEDIN URAL M 929 1.T; METILON 20 PFS LOT 2509196 L-02; MONARCH III IOL, CARTRIDGE D
• Patient Sex: Unknown