ALLEGRO OCULYZER
Received Nov 27, 2019 · Event occurred Oct 31, 2019
Report 3003288808-2019-01171 · MDR key 9387397
Device
Generic name
Device, Analysis, Anterior Segment
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065990641
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
39 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A CUSTOMER REPORTED THAT THE VALUES OF CORNEA FRONT AND CORNEA BACK ARE NOT CORRECT DURING TESTING. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION REQUESTED STATES THAT SINCE THE MEASURED VALUE IS INACCURATE, NO SURGERY WAS PERFORMED. THE PROVIDED MEASUREMENTS WERE PREOPERATIVE MEASUREMENTS. THERE ARE TWO RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT FX, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR PATIENT FH.
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 ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).