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 Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced inability to adapt to halos, trouble with depth perception and clinical reason for explant being inability to adapt to halos, trouble with depth perception.The iol was explanted and exchanged for a non company lens following the initial implant procedure.Additional information has been requested and received stating that the symptoms was resolved.
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).
Additional Manufacturer Narrative
The lens was returned in a plastic bag with a piece of surgical sponge.Solution was dried on the lens.The lens was cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.All product and batch history records are quality reviewed prior to product release.The file indicated the use of a qualified cartridge and handpiece, with a non-qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100% 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 lens with 22.0 diopter, add power +2.2 & 3.2 lens model was replaced with an 20.75 diopter non-company multifocal lens.The exchange for a 1.25 lower diopter difference lens may suggest that the replacement lens was an improved choice for the patient's vision needs.No additional information has been provided at this time.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: 19329050
• Report Number: 1119421-2024-00944
• Device Sequence Number: 3076452
• Product Code: MFK
• UDI-Device Identifier: 00380652413688
• UDI-Public: 00380652413688
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: CCWTT0.220
• Device Lot Number: 15554293
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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: MONARCH III CARTRIDGE C; MONARCH III INJECTOR; OCCUCOAT
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male