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

Model Number	CC60WF
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned inside the associated company iii d cartridge, along with the fully assembled lens case inside the lens carton.Inadequate viscoelastic was observed in the cartridge.The lens was located just inside the nozzle entry area.The lens was rotated and adhered to the interior ceiling of the cartridge.Both haptics were folded onto the anterior optic surface and adhered to the optic in dried solution.The cartridge was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.After the viscoelastic residue was removed from the lens, both haptics were easily pliable using tweezers.A fold test was conducted using folding tweezers.The lens folded and unfolded with no damage or abnormalities observed.The lens was not "too soft" as reported.A product device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A qualified viscoelastic was indicated with the qualified lens/cartridge combination.It is unknown if a qualified handpiece was used.The lens was rotated in the cartridge with the posterior against the interior cartridge ceiling.The root cause may be related to 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 ophthalmic viscosurgical device (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.It is unknown if a qualified handpiece was used.The ifu instructs: company foldable intraocular lenses (iols) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company 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 initial report included, ¿lens is too soft, suctions itself to anterior part of cartridge¿.The company lens material is designed as a soft lens material, making it easy to fold and load into the cartridge, and unfold once delivered into the eye.The lens was posterior surface up, adhered to the interior ceiling of the cartridge with both haptics positioned on the anterior optic surface.This position in a cartridge is similar in appearance to a lens rotating while being advanced.After lens cleaning, both haptics were easily pliable.An acceptable fold test was conducted with no abnormalities.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.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 the 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).
Event or Problem Description
A non-healthcare professional reported that during intraocular lens (iol) implantation, while the lens was being loaded, it was observed to be too soft and suctioned itself to anterior part of the cartridge.The surgery was completed on the same day using a new lens.There was no patient contact with the complaint product.Additional information has been requested but is not available at the time of this report.

• Brand Name: CLAREON ASPHERIC UV ABSORBING 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: 25458316
• Report Number: 1119421-2026-01258
• Device Sequence Number: 18320033
• Product Code: HQL
• UDI-Device Identifier: 00380652396844
• UDI-Public: (01)00380652396844(17)300225(11)260227(10)16209489
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 07/10/2026

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: CC60WF
• Device Lot Number: 16209489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2026
• 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: KELMAN MCPHERSON; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED HANDPIECE
• Patient Age: 79 YR
• Patient Sex: Male