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	Visual Disturbances (2140); Diplopia/Double Vision (4802)
Date of Event	05/23/2025
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 nurse reported that following an intraocular lens (iol) implant procedure, patient had anisometropia and diplopia.The lens was exchanged for an unknown advanced technology intraocular lens (atiol) after the initial implant procedure.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned positioned incorrectly in the lens case in a large biohazard bag.Viscoelastic was dried on the lens.The optic was cut into three portions, typical in appearance to an insertion and removal.One portion has a large broken area of the edge observed.The broken optic material was returned.The middle portion of the optic was cut in a jagged appearance on one side and a smooth linear cut on the other side.The third cut portion of the optic has a small broken edge area.The broken optic material was returned.This optic portion was cracked on the posterior surface and has a cracked area near the anterior edge.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Product history records were reviewed, and documentation indicated the product met release criteria.Associated product information was not provided.The root cause cannot be determined for the reported complaint.Each lens is subjected to a 100 percent 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 power and resolution of the returned lens could not be re-evaluated due to the optic damage.The optic was cut into multiple portions, typical of an insertion and removal.The optic portions had additional lens damage.The company (1.50 cylinder) 21.0 diopter lens was removed and replaced with an unspecified atiol (advanced technology iol).The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information was provided in a2, a3.A, b3, b5, b6, b7, d10 and e4.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that patient had diplopia, vertigo, blurred vision and unexpected astigmatism right eye after surgery.In the surgeon¿s opinion, the product contributed to the event.Patient had unexpected astigmatism due to lens power.The lens was exchanged with company different model and diopter value.The patient issues were resolved.

• 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: 22487842
• Report Number: 1119421-2025-01910
• Device Sequence Number: 20818902
• Product Code: MJP
• UDI-Device Identifier: 00380652457408
• UDI-Public: (01)00380652457408(17)281211(11)241213(10)15967433
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2025

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: CCWTT3
• Device Catalogue Number: CCWTT3.210
• Device Lot Number: 15967433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 08/21/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/21/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male