inforMED
MalfunctionHNI

MST

Received Nov 24, 2014 · Event occurred Jan 11, 2014

Report MW5039305 · MDR key 4284327

Device

Generic name

Mandelburg Irrigating Rotator

Model number

NOT APPLICABLE

Catalog number

UNK

Lot number

NOT APPLICABLE

Product problems

  • Material Fragmentation

Patient

Not reported

  • No Code Available

Narrative

Description of Event or Problem

PATIENT UNDERWENT CATARACT REMOVAL WITH TORIC IOL IMPLANTATION ON (B)(6) 2014. FIRST DAY POST OP EYE EXAM WAS NORMAL. ON ONE WEEK POST-OPERATIVE EXAMINATION WITH USE OF THE SLIT LAMP AND WITH THE EYE DILATED, A SMALL CYLINDER SHAPED PIECE OF METAL WAS IDENTIFIED NEAR THE LENS. THE PATIENT'S EYE EXAM WAS OTHERWISE NORMAL AND SHE DENIED VISUAL DIFFICULTIES. THE PATIENT UNDERWENT OUTPATIENT SURGERY ON (B)(6) 2014 TO REMOVE THE METAL FRAGMENT WITHOUT DIFFICULTY. AFTER REMOVAL, EXAMINATION OF THE METAL FRAGMENT UNDER MICROSCOPE, SHOWED THAT IT WAS PART OF THE TIP FOR THE MANDELBURG IRRIGATING ROTATOR WHICH IS USED WHEN IMPLANTING A TORIC IOL AND WAS USED ON THIS PATIENT A WEEK AGO. KEY POINTS THAT LINK THE METAL PIECE TO THE DEVICE ARE THE FOLLOWING: THE MANDELBURG IRRIGATING ROTATOR WHEN TESTED ON (B)(6) 2014 DID NOT FUNCTION AS PER USUAL. IT ONLY IRRIGATED OUT OF THE END OF THE DEVICE RATHER THAN THROUGH THE TWO SIDE PORTS. THE SIZE/DIAMETER OF THE METAL OBJECT EXACTLY MATCHED THE SIZE/DIAMETER OF THE END OF THE MANDELBURG IRRIGATING ROTATOR. THE METAL OBJECT WAS THE SAME BLUE COLOR AS THE MANDELBURG IRRIGATING ROTATOR TIP.