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

Model Number CNW0T5

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/28/2022

Event Type  malfunction  

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 manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that after implantation of an intraocular lens (iol) the edge of iol was found to be deformed after implanting.Although he/she thought that it was damaged by the implanting process, it turned out that it was already deformed when taking it out of the case when checked through surgical video after the surgery.The surgery was completed without product replacement.The product was not replaced since it was a slight deformation and it was considered that there would be no damage to the patient's health.Additional information was requested.

Manufacturer Narrative

The video shows lens to be damaged as the lens is removed from the iol case.The root cause is potentially manufacturing related.If the iol becomes misaligned in the lens case, iol damage may occur.Based on the results from the product history record, the products met release criteria.Three photos provided.The optic edge appears to be chipped in the two photos taken during surgery, the reported complaint cannot be confirmed from the remaining 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: 15081519
• MDR Text Key: 298071612
• Report Number: 9612169-2022-00348
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652402385
• UDI-Public: 00380652402385
• 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: 11/19/2022

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
• Device Operator: Health Professional
• Device Model Number: CNW0T5
• Device Lot Number: 25322388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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; PROVISC