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

Model Number	CCW0T5
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported during intraocular lens (iol) implant procedure, the toric monofocal rotated 2 times upon removal of irrigation and aspiration (i/a) tip from eye 170 degrees -> 5 degrees.Stayed on 3rd attempt.Additional information has been requested.
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
D.3.Product manufacturing site updated upon receipt of serial number information.G.9.Manufacturer report number updated and reported under 1119421-2025-01397.All the additional information going forward will be provided under manufacturer report number 1119421-2025-01397 for mfg site huntington.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 has been requested and received stating as per surgeon opinion, the product cause or contribute to the event and concerned regarding lens material verses cartridge material causing the lens to be slick and rotate.Postop-operative medication included ophthalmic drops four times a day (qid).

• Brand Name: CLAREON TORIC UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; model farm road; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; model farm road; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21843307
• Report Number: 9612169-2025-00594
• Device Sequence Number: 12922265
• Product Code: MJP
• UDI-Device Identifier: 00380652434034
• UDI-Public: (01)00380652434034(17)260924(11)220926(10)15495542
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 09/24/2026
• Device Model Number: CCW0T5
• Device Lot Number: 15495542
• 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
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/16/2025
• Date Device Manufactured: 09/26/2022
• 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; IRRIGATION AND ASPIRATION (I/A) TIP; LIDOCAINE 1 PERCENT; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; OPERATIVE 5 PERCENT OPHTHALMIC BETADINE; PHENYLEPHRINE 1.5 PERCENT; TETRACAINE 0.5 PERCENT
• Patient Age: 71 YR
• Patient Sex: Male