MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT5
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Posterior Capsule Opacification (4807)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following the intraocular lens (iol) implant procedure, the patient experienced grade 2 posterior capsular opacification and the lens was rotated.Additional information has been requested however no further info received.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received and stated that, the events occurred during the surgery (previously reported as after surgery).It was noticed that cartridge material adheres to posterior surface of lens requiring removal with irrigation and aspiration (i/a) that can sometimes be difficult.Yag laser capsulotomy performed.Lens, capsule polishing performed.
Additional Manufacturer Narrative
Corrected information provided in b.5.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.
Event or Problem Description
Upon further review of the previously reported information, the patient experienced grade 1 posterior capsular opacification (pco), previously reported as grade 2.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21846719
• Report Number: 9612169-2025-00599
• Device Sequence Number: 20821644
• Product Code: MJP
• UDI-Device Identifier: 00380652458580
• UDI-Public: (01)00380652458580(17)260630(11)220702(10)25432908
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2025

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 Expiration Date: 06/30/2026
• Device Model Number: CCWTT5
• Device Catalogue Number: CCWTT5.270
• Device Lot Number: 25432908
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 06/02/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/19/2025; 06/27/2025
• Date Device Manufactured: 07/02/2022
• 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 DELIVERY SYSTEM, INJECTOR; DUOVISC VISCOELASTIC SYSTEM; MONARCH II LOADING FORCEPS; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE
• Patient Age: 46 YR
• Patient Sex: Male