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

Model Number	CNW0T3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that, after intraocular lens implantation surgery, the center part of the lens was found scratched.It was unknown if the scratch was at the time of setting.When the lens was advanced with the plunger, it seemed like the edge part of the lens was advanced and there was no problem.The surgery was completed after replacing the lens with another lens in the same procedure.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
A sample device was 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 (b)(4).
Additional Manufacturer Narrative
Intraocular lens (iol) returned adhered to surgical fabric.Solution is dried on both surfaces of the optic and haptics.Both haptics have fibers adhered.The optic is torn/split-cut dividing the iol in two and scratched/marked-rejectable.Photo shows iol implantation.Lens preparation for the implantation is not provided in the video.Lens appears to be in acceptable position for advancement.When the lens is implanted and has unfolded, a large, deep mark/ line is visible over the iol optic.The product investigation could not identify the root cause for the reported complaint "center part of lens found scratched".Video on lens preparation for the implantation and lens loading into the cartridge was not provided.No issues were observed during the implantation.A deep scratch/ mark was observed on over the iol optic post implantation.All iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.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: 17563388
• Report Number: 9612169-2023-00599
• Device Sequence Number: 20546645
• Product Code: MJP
• UDI-Device Identifier: 00380652409599
• UDI-Public: 00380652409599
• 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): 11/09/2023

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: 03/19/2025
• Device Model Number: CNW0T3
• Device Lot Number: 25298919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2023
• Supplement Date Received by Manufacturer: 10/15/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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 INJECTOR; MONARCH IIICARTRIDGE D; PROVISC
• Patient Sex: Unknown