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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A nonhealth care professional reported that after the intraocular lens (iol) implantation surgery, the lens was explanted in a secondary procedure due to unknown issue.Additional information requested and received stating that the lens was exchanged for a non company lens.No patient harm and the surgeons prognosis was noted as good.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens is cut in half, typical of insertion and removal from the eye.One haptic is broken in the gusset area (not returned).Marks are observed on both sides of the optic that are similar to those left by a surgical instrument used to grasp the lens.A power and resolution inspection could not be conducted due to extensive damage.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The file indicates the use of a qualified cartridge and handpiece.Information regarding the viscoelastic was not provided.It is unknown if qualified combination of associated products were used.The product investigation could not identify a root cause for the reported complaint.Clarification on the reported issue was not provided.Damage was observed to the lens.A power and resolution inspection could not be conducted due to extensive damage.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The company (1.50), 17.5 diopter (add power +2.17/+3.25) lens was replaced with a non company monofocal lens with a diopter of 16.0.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.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: 24723822
• Report Number: 1119421-2026-00636
• Device Sequence Number: 21415479
• Product Code: MJP
• UDI-Device Identifier: 00380652457330
• UDI-Public: (01)00380652457330(17)261025(11)221027(10)15511828
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2026

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: CCWTT3
• Device Catalogue Number: CCWTT3.175
• Device Lot Number: 15511828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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: CLAREON MONARCH IV IOL, INJECTOR.; MONARCH III IOL, CARTRIDGE D.; UNSPECIFIED FORCEPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown