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

Model Number	CC60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implantation procedure, the trailing haptic was missing and became stuck in the cannula.There was patient contact; however, the procedure was completed successfully with same model lens.Additional information was received as there was no patient harm.
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).
Additional Manufacturer Narrative
Correction information provided in b.5.Additional information provided in d.9., h.3., h.6.And h.11.The lens was returned positioned incorrectly in a lens case.The lens was adhered outside the well area of the lens case.Viscoelastic was dried on the lens.One haptic was broken in the gusset area and not returned.The other haptic was broken in the gusset area (returned) and broken in the distal area (returned).Optic was cut into two portions, typical in appearance to damage from an insertion and removal.Both optic portions were returned.The lens case opened and closed securely.There was no damage observed the lens case.The lens carton was smashed at the lower end near the endcap.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.An unspecified company cartridge and unspecified company handpiece were used.The company lens is qualified for use in the company and company cartridges.It is unknown if a qualified cartridge and handpiece were used.A viscoelastic was indicated that is qualified for this lens when used with qualified associated products.Broken haptics were observed which may have been interpreted as the reported complaint.The optic was cut into two portions, typical in appearance to damage from insertion and removal.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company¿s release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.It is unknown if the qualified model of company cartridge and handpiece were used.The ifu instructs: company foldable iols are qualified for use with company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that 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 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.It is unknown if adequate viscoelastic was placed into 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.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 company 20.5 diopter lens was replaced with another company 20.5 diopter lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received as there was no patient harm.The lens was inserted and removed from the patient eye during initial procedure.Upon removal, intraocular lens was difficult to remove.

• 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: 22771086
• Report Number: 1119421-2025-02219
• Device Sequence Number: 9120518
• Product Code: HQL
• UDI-Device Identifier: 00380652396837
• UDI-Public: (01)00380652396837(17)290202(11)250204(10)15986664
• 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,Followup
• Report Date (Section B): 08/26/2025

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: CC60WF
• Device Lot Number: 15986664
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/26/2025
• Date Device Manufactured: 02/04/2025
• 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 LOADING FORCEPS; MONARCH IOL CARTRIDGE; MONARCH IOL INJECTOR; PROVISC OVD
• Patient Age: 67 YR
• Patient Sex: Female