CENTURION Surgical Procedure Pak

Description of Event or Problem

A nurse reported that tip locker error was displayed during calibration for cataract surgery without intraocular lens implantation. The tip is tightened firmly several times, but the error message persisted. A new pk was opened and the error was disappeared. There was no patient contact and no patient impact.This report pertains to phacoemulsification tip involved in this reported event.

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).