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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of an unspecified company cartridge with a non-qualified viscoelastic.The handpiece indicated is qualified for use with this lens, with the use of qualified lens/cartridge combinations.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100 percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the multifocal company (1.50cyl), 23.0 diopter (add power +2.2/+3.2) lens was replaced with a non-company, 22.0 diopter, monofocal lens model.The product has not been received to evaluate.Additional information was provided that, in the surgeon's opinion, the event was not cause by the intraocular lens (iol).Due to the exchange of a multifocal lens to a monofocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced halos and glare.Clinical reason for explant was dysphotopsia.The iol was exchanged for monofocal lens model.Additional information has been requested.

• 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; 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: 19498413
• Report Number: 1119421-2024-01101
• Device Sequence Number: 6652294
• Product Code: MJP
• UDI-Device Identifier: 00380652457446
• UDI-Public: (01)00380652457446(17)270404(11)230406(10)15599662(21)15599662079
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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: CCWTT3
• Device Catalogue Number: CCWTT3.230
• Device Lot Number: 15599662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/09/2024
• Date Device Manufactured: 04/06/2023
• 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: AR40E 22.0 D SN (B)(6); CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; HEALON PRO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male