inforMED
InjuryFSO

QUATERA 700

Received Sep 20, 2023 · Event occurred Jul 3, 2023

Report 9615010-2023-00010 · MDR key 17786475

Device

Generic name

Ophthalmic, Anesthesia, Respiratory, Ent And Dental Devices

Model number

QUATERA 700

Catalog number

6407

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

Unknown

  • Eye Burn
  • Eye Burn

Narrative

Additional Manufacturer Narrative

THE ROOT CAUSE OF THE REPORTED EVENT WAS AN EXCESSIVE ULTRASOUND POWER (U/S POWER) DUE TO USER ERROR. THE INSTRUCTION FOR USE STATES CLEARLY THE ACTIONS TO BE TAKEN TO AVOID APPLICATION OF EXCESSIVE U/S POWER.

Description of Event or Problem

CUSTOMER FROM GB (UNITED KINGDOM) INFORMED THAT A PATIENT CAME IN POST CATARACT SURGERY WITH A WHITE CORNEAL BURN. THE PATIENT UNDERWENT CATARACT SURGERY. THE WHITE CORNEAL BURN WAS DIAGNOSED IN A FOLLOW-UP CLINIC. THE PATIENT RECEIVED NACL 5% AND STEROID EYE DROPS FOR TREATMENT OF THE BURN. PATIENT HAS RECOVERED.