inforMED
InjuryHQS

OPHTHO-BURR 1.0MM

Received Jan 12, 2011 · Event occurred Dec 30, 2010

Report 1971992 · MDR key 1971992

Device

Generic name

Ophthalmic Burr

Model number

*

Catalog number

*

Lot number

68379800

Product problems

  • Metal Shedding Debris
  • Manufacturing, Packaging or Shipping Problem

Patient

41 YR

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

PATIENT WAS SEEN IN URGENT CARE. MD WAS ATTEMPTING TO REMOVE A RUST RING WITH AN OPHTHALMIC BURR DEVICE. THE BURR DEVICE THAT WAS USED CREATED METAL SHARDS THAT WENT INTO THE PATIENT'S EYE, LEAVING A METALLIC FOREIGN BODY AFTER USE. THE PATIENT WAS REFERRED TO OPHTHALMOLOGY FOR FOLLOW UP. PATIENT WAS INFORMED REGARDING THE BURR ISSUE. PATIENT DID NOT COMPLAIN OF VISION DISTURBANCE FOLLWOING PROCEDURE. ALCAINE DROPS WERE USED PREVIOUS TO PROCEDURE SO PATIENT REMAINED TOPICALLY ANESTHETIZED UPON DISCHARGE TO THE OPHTHALMOLOGY OFFICE FOLLOWING THE DEVICE MALFUNCTION. IT APPEARS THAT THE PLASTIC SHEATHS INSIDE THE SEALED PACKAGES ARE NOT INTACT.