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 Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Insufficient Information (4580)
Date of Event	05/27/2025
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, the patient experienced was dislocated lens.Clinical reason for explant was dislocated iol left eye.The iol was exchanged for advanced technology intraocular lenses (atiol) 01 month 12 days following the initial implant procedure.Additional information has been requested.
Event or Problem Description
Additional information has been requested and received stating a normal femto-assisted cataract extraction (ce) surgery was performed with the company lens (lens 1) placed.The intraocular lens (iol) 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.In the surgeon's opinion, the product caused or contributed to the event.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.
Additional Manufacturer Narrative
Additional information was provided in a.2., a.3.A., b.3., b.5., b.6., b.7., d.10.And e.4.H.6.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: 22302074
• Report Number: 1119421-2025-01727
• Device Sequence Number: 8562509
• Product Code: MJP
• UDI-Device Identifier: 00380652457361
• UDI-Public: (01)00380652457361(17)280416(11)240418(10)15840064
• 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
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.190
• Device Lot Number: 15840064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 04/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male