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 Code	Blurred Vision (2137)
Date of Event	05/23/2023
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 intraocular lens (iol) implant procedure, the patient experienced blurry vision and unable to do daily activities as he desires.The iol was exchanged for another company lens model 1 year 7 months after the initial implant procedure.Clinical reason for explant was reported as blurred vision.The patient underwent yag laser procedure and patient distance vision was improved.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in a specimen cup.Blood and solution was dried on the lens.The lens was cut in half, typical of insertion and removal.The optic had multiple small areas of starburst damage observed in the lens material, typical of damage caused by a yag laser procedure conducted post implantation.Power and resolution testing could not be conducted due to the extensive optic damage.A device history record review and a non conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Qualified associated products were indicated.Based on the information provided, the event does not appear to be related to the product.The file indicated that the company lens, 19.5 diopter (add power plus 2.2 or plus 3.2) lens was replaced with a non company 17.5 diopter lens.The lens was exchanged for a lens with a 2.0 lower diopter difference in power.An iol exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Due to the exchange for a 2.0 lower diopter difference lens and the change from a multifocal toric lens to a monofocal lens may suggest that the replacement lens model was an improved choice for the patient's vision needs.Information was provided on the completed questionnaire that the patient had prior lasik and lift flap and laser surgery.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 22577046
• Report Number: 1119421-2025-02023
• Device Sequence Number: 18562362
• Product Code: MJP
• UDI-Device Identifier: 00380652457378
• UDI-Public: (01)00380652457378(17)260712(11)220714(10)15450257
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 09/02/2025

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: 07/12/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.195
• Device Lot Number: 15450257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• 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 II LOADING FORCEPS; MONARCH III IOL , CARTRIDGE D; MONARCH III IOL , INJECTOR; PROVISC OVD; REPLACEMENT LENS: LAL 17.5 70061840719
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male