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 NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, IN THE SURGEON OPINION IT COULD HAVE BEEN PRESSURE FROM THE PLUNGER. THE LENS WAS REMOVED FROM THE PATIENT EYE AND A BACKUP LENS OF SAME MODEL AND DIOPTER WAS IMPLANTED AND COMPLETED THE PROCEDURE ON THE SAME DAY. THERE WAS NO PATIENT HARM.

Additional Manufacturer Narrative

A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF A BROKEN HAPTIC DUE TO SUSPECTED PRESSURE FROM THE PLUNGER; 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. 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 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 INTRA OCULAR 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.