MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that, during intraocular lens (iol) implantation surgery, while advancing the iol into the eye, the insertion rod did not engage the iol edge properly to push the iol through the cartridge and the rod road above the iol.The physician attempted to retract the rod and advance the iol for the second time, but the same thing happened.The cartridge was engaged with the eye and the iol remained within the cartridge.So, the physician decided to get a new iol, cartridge and handpiece and delivered the iol into the eye successfully.As per the physician the more rounded edge of the iol did not engage with the standard handpiece advancement rod.
Additional Manufacturer Narrative
The lens was returned in the company cartridge inside the carton.Viscoelastic was observed.The lens was at the nozzle entry area.The trailing haptic was tucked onto the optic.The leading haptic was extended, which may indicate a plunger override occurred.The cartridge tip had heavy stress.The cartridge had evidence of placement into a handpiece.The company cartridge was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Complaint and product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were indicated.It is unknown if a qualified viscoelastic was used.The root cause could not be determined for the plunger override.The lens was returned in the company cartridge.The leading haptic was extended, which may indicate a plunger override occurred.Top coat dye stain testing was conducted with acceptable results.It is unknown if a qualified viscoelastic was used.The instructions for use (ifu) instructs: company foldable intra ocular lens (iol)s are qualified for use with an alcon qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an alcon qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact alcon.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately half turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.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 ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22062335
• Report Number: 1119421-2025-01450
• Device Sequence Number: 7638988
• Product Code: HQL
• UDI-Device Identifier: 00380652251532
• UDI-Public: (01)00380652251532(17)280903(11)240905(10)15915701
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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 Catalogue Number: SY60WF.225
• Device Lot Number: 15915701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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: MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.
• Patient Sex: Unknown