CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR

Description of Event or Problem

A HEALTH CARE PROFESSIONAL STATED THAT, DURING SURGERY, THE EYE WAS INSERTED WITH MULTIPLE FINE WOUNDS IN THE BASE OF THE OPTIC PART AND LOOP. THE DEFECTIVE IOL REMAINS IN PLACE IN THE PATIENT'S EYE, AND POSTOPERATIVE MONITORING NOTED AS ONGOING. THERE WERE NO PLANS TO REMOVE AND REPLACE THE IOL, NOR ARE THERE ANY PLANS TO RETURN THE ACTUAL PRODUCT. THE HEALTH DAMAGE WAS REPORTED TO BE NONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

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.

Additional Manufacturer Narrative

A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF MULTIPLE FINE WOUNDS IN THE BASE OF THE OPTIC PART AND LOOP; 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. ONE PHOTO ATTACHED TO THE PARENT COMPLAINT WAS REVIEWED BY THE INVESTIGATION SITE. THE PHOTO SHOWS AN IMPLANTED DAMAGED LENS. THE REPORTED ISSUE OF A DAMAGED LENS WAS CONFIRMED; HOWEVER, HOW AND WHEN THE DAMAGE OCCURRED CANNOT BE DETERMINED FROM THIS REVIEW. BASED ON THE EVALUATION OF THE INFORMATION AND PHOTO 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 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.