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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
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 following an intraocular lens (iol) implant procedure, the patient was tested well at a distance and near on vision chart and physician decided to explant the lens.Clinical reason being mentioned as poor quality, waxy in nature.The iol was explanted and exchanged for an unknown monofocal lens following the secondary implant procedure.Additional information received it states that company lens was placed in os (left eye) 8 months prior.Patient complaints of foggy vision since pom (post operative month) i.Reassurance and handholding provided.Lasik (laser-assisted in situ keratomileusis) performed at pom5 for residual -0.50.Posterior capsule clear osi elevated.Patient tested well at distance and near on vision chart but describes the vision as poor quality and waxy in nature.Lens was explanted and exchanged for a different model and diopter company lens following the secondary implant procedure.There was no impact to the patient.Patient states improvement in os vision.

• 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: 20634981
• Report Number: 1119421-2024-02164
• Device Sequence Number: 12604434
• Product Code: MFK
• UDI-Device Identifier: 00380652413480
• UDI-Public: (01)00380652413480(17)261121(11)221123(10)15536318
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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: CCWTT0
• Device Catalogue Number: CCWTT0.120
• Device Lot Number: 15536318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 11/07/2024
• Date Device Manufactured: 11/23/2022
• 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; D AND K LENS FOLDING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; UNSPECIFIED OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female