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
Additional Manufacturer Narrative
This report originally filed as 9612169-2025-00594 from manufacturing site cork ireland.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
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 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).
Additional Manufacturer Narrative
Correction information was provided in h.6.On initial medical device report (mdr) the fda evaluation code of b.17 was submitted.It should have been b.20.Additional information was provided in h.11.The product was not returned.A product 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 root cause for the reported events could not be determined.The lens remains implanted.Regarding the findings of posterior capsule opacification (pco), anterior capsule opacification (aco), phimosis, and intraocular lens (iol) rotation off-axis with the company lenses, customer affairs consulted with the surgeon and provided information related to the reported events.Because these findings are related to clinical outcomes, review of complaints for the reported event types is the primary investigation focus to assess for potential concerns related to pco, aco, phimosis, and lens rotation.Information was also provided that because clinical outcomes are complex with numerous potentially associated clinical and surgical factors, additional information could be discussed with the account representative, including options such as a peer-to-peer communication service called expert opinion medical doctor (md), that the company offers at no charge.Reports of these event types have remained low and stable, with intermittent reporting as expected, based on the potential multifactorial etiology.An additional global review was conducted to look at the reported incidence for each of the above outcomes over the past 3 years.All global complaints are evaluated monthly for adverse trending, and no adverse trends were identified for these events.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 22025952
• Report Number: 1119421-2025-01397
• Device Sequence Number: 9114235
• 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): 07/11/2025

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): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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.; OPERATIVE 5 PERCENT OPHTHALMIC BETADINE.; PHENYLEPHRINE 1.5 PERCENT.; TETRACAINE 0.5 PERCENT.
• Patient Age: 71 YR
• Patient Sex: Male