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

Model Number	CNW0T3
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.The reported complaint cannot be confirmed from the returned photo.Photo review done.Unfortunately, nothing can be determined from these photographs.I would ask if tryptophan blue was used to stain the anterior capsule for this procedure.Its use is not uncommon.The reported complaint cannot be confirmed from the provided photo.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, when a slit photography was conducted a few days after the surgery on (b)(6), a blue-colored clouding was found in the iol.There was no effect on eyesight and the lens still remains in the patient's eye.There was no patient harm.Additional information was received, iol finding of blue colored clouding was getting disappeared.The postoperative visual acuity has not been decreased.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received, intraocular lens finding was almost disappeared about 1 month after the initial surgery.

• 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: 20890518
• Report Number: 9612169-2024-01275
• Device Sequence Number: 7842995
• Product Code: MJP
• UDI-Device Identifier: 00380652409681
• UDI-Public: (01)00380652409681(17)270809(11)230811(10)25692915
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: CNW0T3
• Device Lot Number: 25692915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/25/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/15/2025
• Date Device Manufactured: 08/11/2023
• 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: MONARCH II LOADING FORCEPS.; MONARCH III CARTRIDGE D.
• Patient Sex: Unknown