CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. 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 PHARMACIST REPORTED THAT PLUNGER DID NOT PASS THROUGH THE INTRAOCULAR LENS (IOL) PROPERLY, RESULTING IN DAMAGE TO THE LENS. THE SURGERY WAS COMPLETED WITH A BACKUP LENS. THERE WAS NO PATIENT HARM. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE IMPLANT (IOL) WAS DAMAGED DURING PASSAGE OF THE INJECTOR PISTON, PRIOR TO INJECTION INTO THE EYE. THE IOL WAS NOT RETAINED, IT WAS DISCARDED.

Additional Manufacturer Narrative

A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF DAMAGE TO THE LENS DURING PASSAGE OF THE INJECTOR PISTON; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE REPORTED PRODUCT¿S LOT NUMBER WAS NOT REPORTED, PREVENTING LOT NUMBER SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NONCONFORMANCES. HOWEVER, BEFORE PRODUCTION RELEASE, EACH PRODUCT HISTORY RECORD IS REVIEWED TO ENSURE THAT ALL ASSOCIATED PRODUCTS MEET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. INCONCLUSIVE: BASED ON THE EVALUATION OF THE INFORMATION RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. WHILE THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, THE FOLLOWING FACTORS OUTLINED IN THE REPORTED PRODUCT¿S INSTRUCTION FOR USE (IFU) COULD POTENTIALLY CONTRIBUTE TO AN OUTCOME SIMILAR TO THE REPORTED EVENT. THE IFU STATES THAT THE HANDPIECE MUST BE INSPECTED PRIOR TO EACH USE TO CONFIRM IT IS FREE OF DAMAGE. IT FURTHER EMPHASIZES THAT IF THE HANDPIECE¿PARTICULARLY THE PLUNGER TIP¿APPEARS DAMAGED, BENT, OR OTHERWISE UNFIT FOR PROPER USE, IT MUST NOT BE USED. IN SUCH CASES, USERS ARE INSTRUCTED TO CONTACT THE COMPANY IMMEDIATELY. THE IFU ALSO PROVIDES A LIST OF QUALIFIED CARTRIDGE COMBINATIONS TO USE. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE INTRAOCULAR LENS (IOL) AND POTENTIAL COMPLICATION DURING THE IMPLANTATION PROCESS. 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.