OPHTHO-BURR 1.0MM
Received Jan 12, 2011 · Event occurred Dec 30, 2010
Report 1971992 · MDR key 1971992
Device
Generic name
Ophthalmic Burr
Manufacturer
Beaver Visitec, InternationalModel 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.