MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN A1, A2, A3.A, B3, B5, D6A, AND D11. 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

ADDITIONAL INFORMATION RECEIVED STATING THAT TWO SCRATCHES ON THE IOL NASAL: ONE SCRATCH ON IOL TEMPORAL. THE LENS REMAINED IN THE EYE.

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOLS ARE GETTING SCRATCHED BY THE CARTRIDGE. THE SCRATCHES OCCURRED IN THREE CONSECUTIVE PATIENTS WITH CARTRIDGES FROM THE SAME, AND THE SCRATCH WAS ALWAYS IN EXACTLY THE SAME SPOT, WHERE WE DO NOT TOUCH THE LENS WITH THE LENS FORCEPS. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 2 OF 3.

Additional Manufacturer Narrative

A PRODUCT 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. 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.