MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. 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 Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	08/07/2024
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 facility representative reported that following an intraocular lens (iol) implant procedure, the patient reason as dissatisfied with the current vision, glare when driving and clinical reason for explant being did not tolerate halos & glare.The iol was explanted and exchanged for an unknown atiol following the initial implant procedure.Additional information has been requested and received stating that, patient complains of ghost images when reading.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The product was returned for analysis and the reported complaint could not be confirmed.Iol returned in two segments wrapped in surgical material.Solution is dried on the iol.One haptic is adhered to the optic surface, the other haptic is intact.The optic is torn/split-cut dividing the iol in two and scratched/marked-rejectable with loose fibers and particulate.The root cause for the reported complaint could not be determined.The exchange to a monofocal lens, may suggest that the replacement lens model was an improved choice for the patient's vision needs.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
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 LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20246531
• Report Number: 9612169-2024-00907
• Device Sequence Number: 12571609
• Product Code: MFK
• UDI-Device Identifier: 00380652413404
• UDI-Public: (01)00380652413404(17)250303(11)211010(10)25289526(21)25289526175
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup,Followup
• Report Date (Section B): 01/02/2025

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 Expiration Date: 03/03/2025
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.080
• Device Lot Number: 25289526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 12/09/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 12/07/2024; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2021
• 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 ASPHERIC UV ABSORBING IOL; DUOVISC VISCOELASTIC SYSTEM; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female