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

Model Number	CCWTT3
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, the surgeon noticed that on the lens it appeared to be a crack on the posterior side of a iol.When surgeon examined further and although it was a straight line resembling a scratch, he could actually peel back the edge of the line.He could not remove with suction from i/a (irrigation and aspiration), and it took him about 5 minutes to peel it.After he peeled it off the back of the lens, it was easily suctioned out by i/a with no damage visible in any way on the optic/iol.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Photo shows an implanted iol, there appears to be foreign material on the optic.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
D.3.Product manufacturing site updated due to receipt of serial number of the product.G.9.Manufacturer report number corrected and reported under 1119421-2023-00542.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; model farm road; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; model farm road; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16136049
• Report Number: 9612169-2023-00045
• Device Sequence Number: 6254790
• Product Code: MJP
• UDI-Device Identifier: 00380652457460
• UDI-Public: 00380652457460
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 02/25/2025
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.240
• Device Lot Number: 15273890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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 INJECTOR.; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; UNSPECIFIED OVD.
• Patient Sex: Unknown