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

Model Number	CCWTT0
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported during intraocular lens (iol) implant procedure, the surgeon reported that the lens was stuck in company cartridge and hence the lens was implanted and explanted.The lens was explanted during initial procedure.The procedure was completed on same day using another lens.There was no patient injury.Additional information stated that the patient symptoms were resolved.
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
Upon further review of the reported information, it was confirmed that there was no patient contact with the device.
Additional Manufacturer Narrative
Corrected information was provided in b.2., b.5.And h.11.Upon further review of the reported information, following submission of the initial report, this event does not meet criteria for reporting as a malfunction.No further reports required.Additional information provided in d.10.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 21399764
• Report Number: 1119421-2025-00414
• Device Sequence Number: 8524045
• Product Code: MFK
• UDI-Device Identifier: 00380652413619
• UDI-Public: (01)00380652413619(17)281021(11)241023(10)15940081
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/26/2025

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: CCWTT0.185
• Device Lot Number: 15940081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/26/2025
• Date Device Manufactured: 10/23/2024
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL, CARTRIDGE D
• Patient Sex: Unknown