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	10/20/2025
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 healthcare professional reported that during an intraocular lens (iol) implantation procedure the haptic was broken, the lens was implanted in the patient eye.The surgery was completed on the same day.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.Iol returned pressed against two posts of the lens case base.Solution is dried on the iol.One haptic is broken/torn and not returned, the other haptic is deformed.The optic is deformed.A used company cartridge was returned.Inadequate viscoelastic was observed in the cartridge.No cartridge damage was observed.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Topcoat dye stain testing was conducted with acceptable results.Provided photo shows company cartridge and an iol in a lens case base.The lens is not positioned correctly in the lens case base well; it appears to be pressed against three posts of the well.One haptic is broken and separated from the optic.The lens optic edge appears to be damaged.The company cartridge was shown from the bottom.There did not appear to be adequate viscoelastic in the cartridge.No damage was observed.It cannot be verified if the cartridge was properly seated in a handpiece as the view was from the bottom.The root cause for the reported complaint appears to be related the a failure to follow the instructions for use (ifu).Inadequate viscoelastic was observed in the cartridge.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 23665228
• Report Number: 9612169-2025-02365
• Device Sequence Number: 18716706
• Product Code: HQL
• UDI-Device Identifier: 00380652251518
• UDI-Public: (01)00380652251518(17)280817(11)240819(10)25905779
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: 25905779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown