ALLEGRO OCULYZER
Received Oct 23, 2017 · Event occurred Sep 26, 2017
Report 3003288808-2017-02276 · MDR key 6970827
Device
Generic name
Device, Analysis, Anterior Segment
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065990641
Lot number
ASKU
Product problems
- Incorrect Or Inadequate Test Results
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. (B)(4).
Description of Event or Problem
A SURGEON REPORTED THE ELEVATION READINGS ARE INACCURATE AND IRRELEVANT DURING REFRACTIVE TREATMENT PLANNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
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. WITHOUT SAMPLE THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).