inforMED
InjuryHMY

CBSU MICROKERATOME

Received Sep 9, 2024 · Event occurred Aug 9, 2024

Report 9615659-2024-00002 · MDR key 20169563

Device

Generic name

Cbsu Microkeratome

Manufacturer

Moria Sa

Model number

E0

Catalog number

E0

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

25 YR · Unknown

  • Corneal Abrasion
  • Corneal Abrasion

Narrative

Description of Event or Problem

HEALTHCARE PROVIDER REPORTED BUTTONHOLE. ALSO STATED - - CONSOLE SUCTION WAS 144-147 (SUFFICIENT) AND NEVER LOST SUCTION; - GOT RED LIGHT ON BOTTOM LEFT OF CONSOLE (INDICATING PUMP FAILURE); - WILL SEND IN FULL SYSTEM, BLADE AND COMPLETED FLAP COMPLICATION FORM FOR EVALUATION.