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

Model Number	CC60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.Only part of the lens was returned with one haptic.The optic portion that was returned is broken into serval pieces.Marks are observed on both sides of the optic that are similar to those left by a surgical instrument used to grasp the lens.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 product investigation could not identify a root cause for the reported complaint.Only a portion of the lens was returned for evaluation.Information regarding the capsular tear was not provided.The replacement lens information was not provided.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A non-healthcare professional reported during intraocular lens (iol) implant procedure, the surgeon noticed capsular tear requiring lens to be cut out and removed.The lens was explanted during initial procedure.The procedure was completed on same day.Additional information was requested and received stating that there was no patient harm.

• 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: 23277846
• Report Number: 1119421-2025-02675
• Device Sequence Number: 21071940
• Product Code: HQL
• UDI-Device Identifier: 00380652396752
• UDI-Public: (01)00380652396752(17)290510(11)250512(10)16036093
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CC60WF
• Device Lot Number: 16036093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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; DUOVISC VISCOELASTIC SYSTEM; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male