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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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.
Event or Problem Description
A healthcare professional reported following an intraocular lens (iol) implant procedure, during phacoemulsification, prior to iol implantation, doctor opened a lens, applied viscoelastic on the optic, and used a company cartridge with the company injector.While attempting implantation near the wound, the plunger failed to advance fully.Upon inspection, the trailing haptic was found to be distorted and torn.The lens was removed, and a new iol was implanted using a different company injector.The surgery was completed successfully.There was no harm to patient.Additional information was requested.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.Iol returned positioned correctly in the iol case.One haptic received adhered to the outside of the lens case lid.Solution is dried on the iol.One haptic is broken/torn and is returned, the other haptic is broken/torn and is not returned.The optic is scratched/marked-rejectable.The broken trailing haptic was returned in the tip of the company cartridge.Viscoelastic was observed in the cartridge.The haptic was oriented with the tip toward the loading area.This may indicate the trailing haptic was not in an acceptable position for advancement.The cartridge had evidence of placement into a handpiece.No cartridge damage was observed.The used company cartridge was cleaned for further evaluation.The haptic was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.The root cause for the broken trailing haptic could not be determined.The haptic position in relation to the plunger during advancement cannot be determined.The haptic was oriented with the tip toward the loading area.This may indicate the trailing haptic was not in an acceptable position for advancement.The ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.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: 23094402
• Report Number: 9612169-2025-01865
• Device Sequence Number: 15828531
• Product Code: HQL
• UDI-Device Identifier: 00380652251433
• UDI-Public: (01)00380652251433(17)280923(11)240925(10)25925968
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: 25925968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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 INJECTOR; DISCOVISC OVD; MONARCH III IOL CARTRIDGE D
• Patient Sex: Unknown