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

Model Number	CCWTT0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
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 an lasik procedure, the patient experienced poor vision & glare.Clinical reason for explant malfunction intra ocular lens (iol), mechanical complications.The iol was exchanged for advanced technology intraocular lenses (atiol) with different model lens 8 months 22 days following the initial implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
Corrected information was provided in h.6.(fda product code a26 was updated to a24) additional information was provided in h.3.And h.11.The product was not returned for analysis.The root cause for the reported complaint could not be determined.The instructions for use (ifu) 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 intraocular lens (iol)s, 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.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: 21274389
• Report Number: 9612169-2025-00135
• Device Sequence Number: 8070535
• Product Code: MFK
• UDI-Device Identifier: 00380652413541
• UDI-Public: (01)00380652413541(17)260906(11)220908(10)25487513
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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: 09/06/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.150
• Device Lot Number: 25487513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 04/07/2025
• Date Device Manufactured: 09/08/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown