MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CCWTT0
Medical Device Problem Codes	Product Quality Problem (1506); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
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 health care professional reported that during surgery, loading technician observed small bubble on optic but assumed it was a bubble in the viscoelastic, then it was loaded into the cartridge and inserted to the eye.Upon intraocular lens (iol) insertion, a scratch was observed in the center of optic.Procedure completed on the same day.Additional information has received and it states that it was confirmed to be a defect on the lens that did not move with the insertion of the lens or lens manipulation.Lens was inserted into patient's eye, defect was observed, implant was dissected and removed during initial procedure, replaced immediately.In the surgeon¿s opinion, lens defect was of unknown origin from either manufacturing or shipping and handling.Before implanting tech states that she loaded the implant during irrigation and aspiration (ia) phase, which means it would have been in the cartridge for 5 minutes or less.Patient prognosis was good.Clear pseudophakic vision was achieved and healing as expected post operation 1 week.No patient impact was reported.

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 21606190
• Report Number: 1119421-2025-00687
• Device Sequence Number: 9217759
• Product Code: MFK
• UDI-Device Identifier: 00380652413664
• UDI-Public: (01)00380652413664(17)280623(11)240625(10)15877058
• 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
• Report Date (Section B): 03/14/2025

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: CCWTT0
• Device Catalogue Number: CCWTT0.210
• Device Lot Number: 15877058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/14/2025
• Date Device Manufactured: 06/25/2024
• 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: GRIP GROOVES; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 69 YR
• Patient Sex: Male