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	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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).
Event or Problem Description
A non-healthcare professional reported that during the intraocular lens (iol) implant procedure, the haptic was torn off while loading the lens.The procedure was completed on same day with confirmed contact with the patient.Additional information was received along with a photograph, stating that the lens was immediately removed once the surgeon noticed the missing haptic, and a new iol was placed in the capsular bag without any harm to the patient.Additional information has been requested however no further information available.
Additional Manufacturer Narrative
Additional information was provided in h.3.And h.11.The product was not returned.Two photos were provided showing the same view of the lens.The lens is lying on a white piece of paper.One haptic is broken in the gusset area (not shown).The optic is damaged with split and cracks from the edge to the center of the lens.Edge damage on the optic is observed.A 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.The account indicated the use of qualified associated products.Based on our observation of the attached photos, the haptic is broken.The photo also shows other unreported lens damage that may have been caused when explanted the lens.The account indicated the product was not available to evaluate.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.The instruction for use (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 ophthalmic visco surgical device (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).

• 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: 22919879
• Report Number: 1119421-2025-02343
• Device Sequence Number: 21430036
• Product Code: HQL
• UDI-Device Identifier: 00380652396875
• UDI-Public: (01)00380652396875(17)290310(11)250312(10)16006296
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/10/2025

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: 16006296
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/10/2025
• Date Device Manufactured: 03/12/2025
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 63 YR
• Patient Sex: Male