InjuryHLN
HUMPHREY INSTRUMENT
Received Aug 24, 2001 · Event occurred Jul 16, 2001
Report 349265 · MDR key 349265
Device
Generic name
Ultrasonic Biometer
Manufacturer
Zeisis Humphrey SystemModel number
820Catalog number
820-4152
Lot number
*
Product problems
- Malfunction
Patient
68 YR
- Surgical procedure
Narrative
Description of Event or Problem
ON AUGUST 7, 2001, IT WAS DISCOVERED THAT PT WOULD NEED SURGERY TO REPLACE LENS THAT WAS INSERTED IN THE PT'S LEFT EYE. VISION IN LEFT EYE WAS 20/70 PRE OPERATIVE. VISION IN LEFT EYE WAS 20/400. PRE-OPERATIVE AXIAL LENGTH WAS 24.31. RECHECK OF AXIAL LENGTH WAS 22.99. USING THE SAME ULTRASONIC BIOMETER. CALIBRATION WAS CHECKED AND WAS CORRECT.