ALLEGRO TOPOLYZER VARIO
Received Jul 10, 2019 · Event occurred Jun 20, 2019
Report 3003288808-2019-00708 · MDR key 8776836
Device
Generic name
Topographer, Corneal, Ac-powered
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065990710
Lot number
NA
Product problems
- Incorrect Measurement
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact 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 DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. (B)(4).
Description of Event or Problem
A FACILITY REPRESENTATIVE REPORTED DURING MEASUREMENT TESTING PRIOR TO REFRACTIVE TREATMENT, THE MEASUREMENTS WERE NOT CORRECT. THE MEASUREMENTS WERE NOT USED DURING SURGERY AND THERE WAS NO PATIENT IMPACT.
Additional Manufacturer Narrative
DURING TECHNICAL REVIEW THE FIELD SERVICE ENGINEER (FSE) PERFORMED THE CALIBRATION WITH MODEL EYE AND FOUND ALL MEASUREMENT VALUES IN RANGE. MEASUREMENT WAS ALSO CHECKED ON HUMAN EYES AND FOUND TO BE NORMAL. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).