inforMED
MalfunctionHLM

IOLMASTER

Received May 4, 2010 · Event occurred Jan 26, 2010

Report 1717016 · MDR key 1717016

Device

Generic name

Intraocular Lens Testing

Manufacturer

Carl Zeiss

Model number

V 4.08

Catalog number

*

Lot number

*

Product problems

  • Computer Software Problem
  • Incorrect Measurement
  • Structural Problem

Patient

*

  • Visual Impairment

Narrative

Description of Event or Problem

IOL MASTER SCREENING WAS DONE PRE-OP FOR CATARACT SURGERY, R EYE READING ACCURATE, L EYE READING INNACCURATE BUT NO ALARM OR HIGHLIGHT RELATED TO THE SIZE DISCREPANCY. CATARACT SIZE ORDERED AS INDICATED BY TEST RESULT AND ON POST OP DAY ONE PATIENT FOUND TO HAVE WORSE VISION AND IT WAS DETERMINED THAT THE WRONG SIZE LENS WAS IMPLANTED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================INSTEAD OF REJECTING A FALSE MEASUREMENT, THE MACHINE USED IT TO INCORRECTLY CALCULATE A WRONG LENS IMPLANT SIZE. THIS IS BECAUSE WHEN THE CATARACT IS TOO DENSE, THE IOLMASTER CAN NOT GIVE AN ACCURATE MEASUREMENT. INSTEAD OF REPORTING AN ERRONEOUS MEASUREMENT, IT SHOULD INDICATE THE NEED FOR A DIFFERENT TEST. IT MAY BE HELPFUL TO ALLOW FOR CALIBRATION OF THE SOFTWARE IF THE TEST IS INACCURATE. THE PHYSICIAN REALIZES THERE ARE HUMAN FACTORS INVOLVED BUT FEELS THERE COULD BE AN IMPROVEMENT TO THE SOFTWARE/REPORTING OUT OF RESULTS.