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

Model Number	CNW0T6
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Photo review: provided images 'photo 1' and 'photo 1 marked' show an implanted iol.There appears to be a dark line/mark over the iol optic.The origin of the observed dark line/mark cannot be verified from the returned photo and without the evaluation of the physical product.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, a black line was seen on the surface of the iol when the iol was inserted into the eye.The scratch or dirt could not be removed after cleaning the front and back of the optical part with irrigation and aspiration.The surgery was completed as it was, the lens still remains in the patients eye.The injector and cartridge used are being checked and there was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in h.11.Video review: the returned video shows the procedure of intraocular lens (iol) implantation.However, only the cartridge nozzle tip is visible in the video, the remaining part of the cartridge is not shown.Additionally, the steps related to cartridge preparation are not demonstrated.The cartridge (tip only) appears when the iol is being implanted.The iol is successfully implanted.A dark line or mark is observed on the iol optic area after implantation.The origin of the observed line or mark cannot be confirmed from the returned video.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 21633961
• Report Number: 9612169-2025-00415
• Device Sequence Number: 9372112
• Product Code: MJP
• UDI-Device Identifier: 00380652411172
• UDI-Public: (01)00380652411172(17)271022(11)231024(10)25742034
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: CNW0T6
• Device Lot Number: 25742034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/13/2025
• Date Device Manufactured: 10/24/2023
• 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; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown