ALLEGRO OCULYZER
Received Dec 16, 2019 · Event occurred Oct 31, 2019
Report 3003288808-2019-01236 · MDR key 9473665
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
69 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. 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).
Description of Event or Problem
A CUSTOMER REPORTED THAT THE VALUES OF CORNEA FRONT AND CORNEA BACK ARE NOT CORRECT DURING TESTING. 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 FH, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR PATIENT FX.