MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT5
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient has poor vision.Clinical reason for explant poor vision post operation and patient dissatisfaction.The iol was exchanged for advanced technology intraocular lenses (atiol) model lens 1 month 2 days following the initial implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in a plastic specimen cup.The lens was removed and allowed to air dry prior to evaluation.Viscoelastic residue was observed on the lens.One haptic distal anterior edge was torn.The other haptic was torn (still attached) in the gusset area.The optic was broken (possibly cut) into pieces.One of the optic portions has additional torn area from the edge towards the optic center.Product history records were reviewed and 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 returned in pieces, typical of an insertion and removal.Haptic and optic damage were observed.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power (sphere and cylinder) and resolution of the returned lens could not be re-evaluated due to the optic damage.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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21357258
• Report Number: 1119421-2025-00355
• Device Sequence Number: 8482110
• Product Code: MJP
• UDI-Device Identifier: 00380652458405
• UDI-Public: (01)00380652458405(17)250321(11)211028(10)15292202
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 02/11/2025

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: 03/21/2025
• Device Model Number: CCWTT5
• Device Catalogue Number: CCWTT5.180
• Device Lot Number: 15292202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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 DELIVERY SYSTEM, CARTRIDGE D.; RPL LENS (ATIOL),J&J DRT300 18.5D.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown