MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Nausea (1970); Red Eye(s) (2038); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Photophobia (4801); Diplopia/Double Vision (4802)
Date of Event	07/09/2024
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 healthcare professional reported that following the intraocular lens (iol) implant procedure, the patient was not happy with her vision.The patient experienced redness , nausea , bumps under eye.She has also experienced glare and light sensitivity.The symptoms were continuing and planned to explant and exchange of lens.Additional information has been received that patient also experienced halos.
Additional Manufacturer Narrative
Additional information provided in a.2.,b.5.,d.6.B.,h.3., h.6.And h.11.The product was not returned for analysis.The root cause for the reported complaint could not be determined.The ifu (instructions for use) states that some visual effects may be expected due to the superposition of focused and unfocused multiple images.These may include some perception of halos, radial lines around point sources of light(starbursts) under night-time conditions, or glare, as well as other visual symptoms.As with other multifocal iols, there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal iol.Based on the results from the product history record, the products met release criteria.Investigation has been completed based on current information.No further action is warranted at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that the lens was explanted and implanted with non-company lens.There was no complications and symptoms were resolved.

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC 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: 20638306
• Report Number: 9612169-2024-01134
• Device Sequence Number: 7432228
• Product Code: MFK
• UDI-Device Identifier: 00380652408172
• UDI-Public: (01)00380652408172(17)270628(11)230630(10)25677289
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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 Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.225
• Device Lot Number: 25677289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 06/30/2023
• 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: ARGOS BIOMETER; CLAREON MONARCH IV IOL INJECTOR; MONARCH III IOL CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Female