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

Model Number	CC60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.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.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 iol found to have a scratch on lens after it was placed in the eye.The incision was not enlarged to explant the lens.There was no additional surgical intervention performed related to the issue.There was no impact to the patient.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The lens was returned for evaluation.Solution is dried on the lens.Scratches are observed on the optic.Marks are observed on both sides of the optic that are similar to those left by a surgical instrument used to grasp the lens.The lens is cut in half, typical of insertion and removal from the eye.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.Qualified associated products were indicated.Lens damage was observed.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.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 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.Company ifu: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the original surgery was completed on the same day.
Additional Manufacturer Narrative
Imdrf code of f1905 was missed to add in previous reports.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: 23321525
• Report Number: 1119421-2025-02706
• Device Sequence Number: 21309623
• Product Code: HQL
• UDI-Device Identifier: 00380652396608
• UDI-Public: (01)00380652396608(17)270219(11)230221(10)15592442
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 12/12/2025

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: 15592442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 11/17/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/16/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; MONARCH IOL DELIVERY SYSTEM, INJECTOR; UNSPECIFIED LOADING FORCEPS
• Patient Sex: Female