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

Model Number	CNW0T3
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.It remains implanted in the patient's eye.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Photo provided showing implanted iol on a monitor screen.There appears to be a mark/material on the iol.The exact location of the mark/material cannot be confirmed.The complainant indicates the use of opegan-hi as a viscoelastic, which is not qualified for use with company model, this is not a qualified company product combination.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during intraocular lens (iol) implantation procedure, a scratch or foreign material was found in the optic after iol insertion.The surgery was completed without product replacement.The lens remains implanted in patient's eye.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
Based on the information provided by the customer, the most likely root cause is failure to follow instruction for use (ifu), as the surgeon states the use of non-qualified viscoelastic.The use of an unqualified combination may cause damage to the intraocular lens (iol) and potential complications during the implantation process.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: 16814903
• Report Number: 9612169-2023-00320
• Device Sequence Number: 20257535
• Product Code: MJP
• UDI-Device Identifier: 00380652409698
• UDI-Public: 00380652409698
• 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): 07/07/2023

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: 03/25/2026
• Device Model Number: CNW0T3
• Device Lot Number: 25381081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2022
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; OPEGAN-HI
• Patient Sex: Unknown