CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE DOCTOR HAD TO ASPIRATE A PIECE OF PLASTIC THAT APPEARED ON THE OPTIC OF THE LENS. AFTER REMOVING THE PLASTIC PIECE, THEY NOTICED THAT THE LENS WAS MARKED. THEY STATED THAT IT APPEARED THE PLASTIC MATERIAL CAME FROM THE CARTRIDGE USED FOR IMPLANTATION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

Additional Manufacturer Narrative

A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).