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

Model Number	SY60WF
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A surgeon reported during a phacoemulsification (phaco) and intraocular lens (iol) implant procedure, the iol was incorrectly positioned in the narrow part of the cartridge, which led to pinching and detachment of the haptic element from the optical part of the iol as it exited the cartridge.This was discovered in the capsular bag.The lens with the detached haptic was explanted, and an identical iol was implanted.The surgery was completed without complications.The temperature conditions for storing and using the ovd and the iol were maintained.Additional information has been requested and received stating in the surgeon's opinion the surgeon believed the issue was with the lens.Surgeon considered that suspect lens was less durable than other model of same company lens and that problems with it occur more frequently.Lens was replaced immediately during the surgery with a similar lens available at the clinic.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 23931415
• Report Number: 9612169-2025-02635
• Device Sequence Number: 5610073
• Product Code: HQL
• UDI-Device Identifier: 00380652251440
• UDI-Public: (01)00380652251440(17)280822(11)240824(10)25912316
• Combination Product (Y/N): N
• Initial Reporter Country: BO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: 25912316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/30/2025
• Date Device Manufactured: 08/24/2024
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Unknown