MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON TORIC UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCW0T3
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non healthcare professional reported that during intraocular lens (iol) implant procedure, the lens was stuck in the injector.There was patient contact and surgery was completed.Additional information has been received that the lens was inserted inside eye but was never released.There was no patient harm.
Additional Manufacturer Narrative
The lens was returned advanced to the nozzle entry area in a company cartridge wrapped in gauze with the dissembled lens case.The lens had been loaded upside down.Both haptics were extended.This may indicate a plunger override occurred.The cartridge had no evidence of placement into a handpiece.This may indicate it was not properly seated.The company cartridge was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.A device history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Qualified associated products were indicated.The root cause for the reported "lens stuck is related to a failure o follow the (instructions for use) ifu.The lens was loaded posterior surface up (upside down), not anterior surface up per the diagram etched at the loading area.Both haptics were extended which may indicate a plunger override occurred.The cartridge had no evidence of placement into a handpiece.This may indicate the cartridge was not properly seated, which could cause the plunger to be misaligned during 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 ifu instructs to slide the cartridge fully forward into the handpiece slot until it is secured firmly into position.Important: 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 company.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 ½ 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).

• Brand Name: CLAREON TORIC UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 22773108
• Report Number: 1119421-2025-02229
• Device Sequence Number: 13083559
• Product Code: MJP
• UDI-Device Identifier: 00380652431880
• UDI-Public: (01)00380652431880(17)281231(11)250102(10)15967532
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/11/2025

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: CCW0T3
• Device Lot Number: 15967532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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 II FORCEPS; MONARCH III CARTRIDGE D; MONARCH INJECTOR, UNSPECIFIED; PROVISC
• Patient Age: 70 YR
• Patient Sex: Male