CENTURION SURGICAL PROCEDURE PAK

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 HEALTHCARE PROFESSIONAL REPORTED THAT THE (PHACOEMULSIFICATION) PHACO POWER WAS WEAKER THAN USUAL DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENS IMPLANTATION). THE ISSUE OCCURRED AS THE HOSPITAL WAS REUSING THE SLEEVE INSTEAD OF USING AS SINGLE-USE ITEM. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE SLEEVE WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO THE INFUSION SLEEVE INVOLVED IN THIS REPORTED EVENT.