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	Insufficient Information (4580)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, scratched lens.The lens was explanted in initial procedure.The procedure was completed with another iol.Additional information was requested.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The used company cartridge was not returned for evaluation.A photo was provided of the damage lens.The photo was a distorted image of a monitor screen.What appeared to be parallel stutter scratches were visible on the right and left side of the optic.Product history records were reviewed and documentation indicated the product met release criteria.The associated company cartridge and viscoelastic information was not provided.A photo was provided of the lens damage.The damage observed was similar in nature to damage detected using cavity 173 company cartridges.A company cartridge market action was initiated for a mold attribute on cavity 173 cartridges that was found to cause lens damage.Although the reporter did not provide a lot number or any identification traceable to the company cartridge manufacturing documentation and no product was returned, this facility was in possession of product related to the company cartridge market action, and therefore this event may be related.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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20799597
• Report Number: 1119421-2024-02317
• Device Sequence Number: 12451317
• Product Code: HQL
• UDI-Device Identifier: 00380652396769
• UDI-Public: (01)00380652396769(17)280429(11)240501(10)15847637
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 15847637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 04/11/2025
• Date Device Manufactured: 05/01/2024
• 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, INJECTOR
• Patient Sex: Unknown