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	Optical Decentration (1360)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that following an femto-assisted cataract extraction (ce) surgery with intraocular lens (iol) implant procedure, the patient experienced a dislocated lens.The clinical reason for explant was dislocated iol in the left eye.The iol (lens 1) was well centered at the end of the case.Approximately 1 meter post-op, the patient was referred back with suboptimal visual acuity (va).The iol was noted to be nasally decentered by approximately 2 millimeters (mm), and the patient was taken to the operating room (or), where the iol could not be re-centered.The iol was lifted into the anterior chamber (ac), and one haptic was found to be missing.The amputated haptic was not retrieved or seen.The iol was explanted and replaced with a same model, same diopter, same company iol (lens 2), which was also found to be decentered on post-operative day 1 (pod 1), presumably due to the remaining haptic in the bag.The patient's issues had not yet resolved.The surgeon gave a good prognosis.In the surgeon's opinion, the product caused or contributed to the event.Additional information has been requested.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is:(b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.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.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.This was the replacement lens for a previously dislocated intraocular lens (iol).Information was provided that the initial lens was well centered when implanted with no issue at the time of implantation.One month after implant the lens was decentered and a broken haptic was observed.No trauma was reported by the patient.The broken haptic was not found when the lens was removed.The lens was removed and replaced with the lens for this file (same model).The second lens was reported to have dislocated at one day post op, possibly due to the retained haptic.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 22541405
• Report Number: 1119421-2025-01968
• Device Sequence Number: 8458760
• Product Code: MJP
• UDI-Device Identifier: 00380652457361
• UDI-Public: (01)00380652457361(17)281124(11)241126(10)15941051
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.190
• Device Lot Number: 15941051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 11/26/2024
• 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: DUOVISC VISCOELASTIC SYSTEM.; IMPLANTATION/FOLDING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Patient Age: 72 YR
• Patient Sex: Male