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

Model Number	CNW0T7
Medical Device Problem Codes	Material Discolored (1170); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, there was something like a flat burr at the root of the iol haptic after implantation.Cast molding was not completed, and surgeon suspected that there may have been some raw material left over (he described that it is like the winged dumpling).The surgery was completed without product replacement.The lens still remains in the patient's eye.Additional information has been received and stated that, the physician suspected that the color was slightly darker and protrudes in an irregular shape from the base of the haptic to the edge of the optics.
Additional Manufacturer Narrative
The product was not returned for analysis.Photo shows iol(intraocular lens), the gusset area is marked in one of the pictures pointing at darker area of the gusset area.The iol in the photo is implanted.Multipple marks/ stains/ buurs are visible around the edge and over the iol surface.No confirmation can be made on the reported complaint from the provided photo.Based on our observation of the attached photo, marks, burr is visible over the iol optic edge and srface.A definitive determination of damage 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).

• 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: 18527164
• Report Number: 9612169-2024-00066
• Device Sequence Number: 20765347
• Product Code: MJP
• UDI-Device Identifier: 00380652402460
• UDI-Public: 00380652402460
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: 05/11/2026
• Device Model Number: CNW0T7
• Device Lot Number: 25416444
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• 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; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown