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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following intraocular lens (iol) implant procedure, patient experienced like looking through a plastic sheet.The lens was then exchanged with unknown monofocal iol following the initial implant procedure.The clinical reason for explantation was mechanical complication, pupil was off center thus iol was off center.Additional information received stating that there was pupil irregularity.The lens was then exchanged with company different model and different diopter.In the surgeons opinion product contributed to event.
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).
Additional Manufacturer Narrative
Product history records were reviewed, and documentation indicated the product met release criteria.The file indicated the use of a qualified company cartridge with a company handpiece.The company handpiece will not physically accommodate the company cartridge.This may have been reported in error.The file indicated the use of a qualified viscoelastic.However, associated products are insignificant to the reported complaint.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100 percent 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 21.0 diopter add power +2.2 & 3.2 lens model was replaced with a monofocal company 20.5 diopter lens model.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.No additional information has been provided at this time.File will be reopened and updated if new information is received.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; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21716025
• Report Number: 1119421-2025-00857
• Device Sequence Number: 14638939
• Product Code: MFK
• UDI-Device Identifier: 00380652413664
• UDI-Public: (01)00380652413664(17)280106(11)240108(10)15775838
• 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: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.210
• Device Lot Number: 15775838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/13/2025
• Date Device Manufactured: 01/08/2024
• 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; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; UNSPECIFIED INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown