MONARCH IOL DELIVERY SYSTEM, CARTRIDGE

Additional Manufacturer Narrative

A PRODUCT 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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Description of Event or Problem

A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD RIFT AFTER INSERTION. THE LENS WAS INSPECTED BEFORE LOADING, AND THE SAME NURSE LOADED IT AS PER USUAL PRACTICE, USING THE SAME VISCOELASTIC AND THE SAME TYPE OF CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS CAREFULLY INSPECTED BEFORE LOADING AND NO TEARS WAS OBSERVED. AFTER THE LENS UNFOLDED IN THE PATIENT EYE A SIGNIFICANT TEAR WAS SEEN. THE TEAR MUST HAVE OCCURRED IN CONNECTION WITH THE LOADING OF THE LENS. DURING LOADING, THE UTMOST CARE WAS TAKEN, THE OPTIC WAS NOT TOUCHED, AND ALL CONTACT WAS MADE ONLY WITH THE HAPTICS. THE COMPANY CARTRIDGE WAS USED.