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

Model Number	SY60WF
Medical Device Problem Codes	Break (1069); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health care professional reported that during calibration/setup of an intraocular lens (iol) implant procedure, iol was stuck to the cartridge wall, attempted to push the iol with a viscoelastic and plunger from 2 sides, rinse with a solution, when trying move the lens with plunger haptic broke off.The patient was not in contact with the iol and there was no patient harm.The procedure was completed with another lens.Additional information has been requested but is not available at the time of this report.

• 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: 24333232
• Report Number: 9612169-2026-00332
• Device Sequence Number: 14655396
• Product Code: HQL
• UDI-Device Identifier: 00380652251310
• UDI-Public: (01)00380652251310(17)280114(11)240116(10)25783724
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2026

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: 25783724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 01/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown