LUXOR OPHTHALMIC MICROSCOPES

Description of Event or Problem

A CUSTOMER REPORTED THAT AN OPHTHALMIC MICROSCOPE CONTROL HANDLE WAS LOOSENED. THE DETAILS OF THE PROCEDURE AND PATIENT HEALTH IMPACT HAVE NOT BEEN REPORTED.

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).