inforMED
MalfunctionPZG

CUSTOMEYES

Received Nov 18, 2021

Report 3002808441-2021-00008 · MDR key 12839109

Device

Generic name

Cataract Procedure Pack.

Model number

588076

Lot number

3366687

Product problems

  • Material Separation
  • Material Separation

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CUSTOMER REPORTED THAT DURING A CATARACT PROCEDURE THE SURGEON WENT TO INJECT THE ANTIBIOTIC AND NOTICED A BLACK FIBRE IN THE BARREL OF THE SYRINGE, OBVIOUSLY IT WAS IMMEDIATELY WITHDRAWN AND A NEW SYRINGE WAS USED. IT WAS REPORTED THAT IT LOOKS LIKE A STRAND OF RUBBER STILL ATTACHED TO THE RUBBER BUNG IS LOOSE.