ULTRAFLOW BIMANUAL I/A HANDPIECE SET DSP

Additional Manufacturer Narrative

A SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND AND THE PRODUCT WAS RELEASED ACCORDING TO ACCEPTANCE CRITERIA. A 100% FINAL INSPECTION FOR THIS PRODUCT WAS PERFORMED. A ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED. VARIOUS CAUSES ARE POSSIBLE FOR THIS KIND OF POTENTIAL DAMAGE. THE MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDS AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A SURGEON REPORTED THAT THE PATIENT EXPERIENCED A RIGHT EYE EQUATORIAL CAPSULAR RUPTURE DUE TO A ROUGH IRRIGATION/ASPIRATION HANDPIECE TIP DURING A CATARACT PROCEDURE. A PARS PLANA VITRECTOMY WAS PERFORMED, EXPLANTATION OF THE INTRAOCULAR LENS AND A SECONDARY INTRAOCULAR LENS WAS IMPLANTED IN THE SULCUS. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS FOLLOWING THE PROCEDURE. THE EVENT HAS RESOLVED.