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

Model Number CNW0T4

Device Problem Scratched Material (3020)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

A sample device was not 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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during implantation of an intraocular lens (iol), two scratches were observed at the iol optic after implantation.The sample is not available as it still remains in the patient's eye.Additional information was requested and received.

Manufacturer Narrative

Video shows lens implantation with company accessories.Lens preparation for the implantation is not provided in the video.When the cartridge comes in the picture, the lens is advanced at the nozzle tip.Lens position for advancement cannot be confirmed due to the quality of the video.The lens is rapidly advanced and implanted.2 marks are observed at the edge of the optic at the opposite sides of the leading haptic.The complainant indicates the use of non company viscoelastic which is not qualified for use with the associated lens model.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC IOL
• Type of Device: 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: 15249027
• MDR Text Key: 300342695
• Report Number: 9612169-2022-00404
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652402347
• UDI-Public: 00380652402347
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNW0T4
• Device Lot Number: 25322390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV IOL INJECTOR.; MONARCH III IOL CARTRIDGE D.; OPEGAN-HI.