ALLEGRO TOPOLYZER VARIO
Received Aug 23, 2017 · Event occurred Jul 31, 2017
Report 3003288808-2017-01948 · MDR key 6814343
Device
Generic name
Topographer, Corneal, Ac-powered
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065990710
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A DOCTOR REPORTED INCORRECT READINGS AND VALUES FOR REFRACTIVE TREATMENT PLANNING. ADDITIONAL INFORMATION RECEIVED; THE READINGS AND MEASUREMENTS WERE NOT USED FOR TREATMENT.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).