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 Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision.Clinical reason being mentioned as mechanical complication.The iol was explanted and exchanged for an unknown atiol (advanced technology intraocular lens) in the secondary implant procedure.Additional information has been requested.
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
Additional information has been provided in b.5., b.7., d.9., d.10., e.4., h.3., h.6., and h.11.The lens was returned inside a non-company self sealed blue pouch.The lens was taped to a small piece of white paper.Viscoelastic was dried on the lens.One haptic was broken into the optic/haptic junction.The lens was soaked and cleaned with klrp to attempt further evaluation.After removal from the paper, adhesive was still present on the lens.The optic anterior has scratches from the edge toward the center.The optic posterior also was scuffed and scratched in three areas.The posterior haptic/optic junction was also scratched.The power (sphere and cylinder) and optical resolution of the returned lens could not be retested due to the haptic and optic damage combined with the residue of the adhesive from the tape used to transport the lens.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The root cause cannot be determined for the reported complaint.The lens was damaged.Each lens was 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.The power and resolution of the returned lens could not be re-evaluated due to the lens damage and the remaining adhesive material from the tape used to return the lens.Information was provided that indicated the multifocal toric 21.5 diopter (add power 2.2/3.2 diopter) lens was removed and replaced with a non-company monofocal toric lens of the same diopter.Due to the exchange of multifocal toric lens for a monofocal toric lens of the same diopter, this suggests that a monofocal toric lens may have been an improved choice for the patient's vision needs.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated the iol was exchanged for non company lens in the secondary implant procedure.No patient impact was reported.

• 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: 21525922
• Report Number: 1119421-2025-00594
• Device Sequence Number: 9696386
• Product Code: MJP
• UDI-Device Identifier: 00380652457415
• UDI-Public: (01)00380652457415(17)260629(11)220701(10)15440903
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: 06/29/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.215
• Device Lot Number: 15440903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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 IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; PROVISC; UNSPECIFIED FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown