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

Model Number	CNW0T3
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported during the intraocular lens implantation a shiny reflecting foreign material which seemed like a piece of metal was found in the lens optic after implantation.The foreign material could not be removed easily and the surgery was completed without product replacement.The product still remains in the eye.Additional information has been requested and received stating after iol insertion, iop is slightly elevated at 23.8 mmhg, but causality is unknown.
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.There have been no other complaints reported in the lot number.A photo was provided of the lens in the eye.The lens is anterior surface up.Reported complaint cannot be confirmed from the provided the manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A photo was provided of the lens in the eye.The lens is anterior surface up.An area is circled on the photo, foreign material can be seen within the circled area.The exact location of the foreign material cannot be confirmed.Video review: video does not show lens preparation.The cartridge comes into view, the iol is in the pause location.The iol appears to be folded correctly.The iol is advanced intermittently with the plunger, as the iol unfolds in the eye, the haptic is dislodged from its resting place on the optic using surgical tool.There appears to be a piece of shiny foreign material where the haptic had been resting on the optic.Based on our observation of the attached photo, there is foreign material on the iol.A definitive determination of the iol condition cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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: 16553390
• Report Number: 9612169-2023-00222
• Device Sequence Number: 16877236
• Product Code: MJP
• UDI-Device Identifier: 00380652409742
• UDI-Public: 00380652409742
• 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): 06/05/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2025
• Device Model Number: CNW0T3
• Device Lot Number: 25298875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 05/07/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female