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

Model Number	CNW0T4
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.The product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The complainant indicates the use of non company viscoelastic, which is not qualified for use with company lens 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 following implantation of an intraocular lens (iol) the that a foreign material of about 3mm was found adhered to the rear surface of the iol after implanting.The foreign material was not there when it was set up.It may be deposits from the injector.The foreign material was removed by forceps and the surgery was completed without product replacement.Additional information was requested.
Additional Manufacturer Narrative
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
Additional information was requested and received product information.
Additional Manufacturer Narrative
The product was not returned for analysis.The received photo shows an implanted iol (intraocular lens)on a monitor screen, there appears to be a mark/fibre in the middle of the optic and also marks near the edge of the optic.The exact location of the marks cannot be confirmed.Based on our observation of the attached photo, there appears to be foreign material on the iol.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: 15321343
• Report Number: 9612169-2022-00434
• Device Sequence Number: 5203240
• Product Code: MJP
• UDI-Device Identifier: 00380652410069
• UDI-Public: 00380652410069
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2022

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: 01/31/2024
• Device Model Number: CNW0T4
• Device Lot Number: 21285286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/15/2022; 11/01/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/07/2022; 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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: INTREPID AUTOSERT HANDPIECE.; MONARCH III IOL CARTRIDGE D.; OPEGAN-HI.
• Patient Sex: Unknown