ALLEGRO OCULYZER
Received Aug 27, 2018
Report 3003288808-2018-01514 · MDR key 7819480
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
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION PROVIDED. 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 IDENTIFIED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
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 CUSTOMER REPORTED THE INDEX OF HEIGHT DECENTRATION (IHD) WAS ABNORMAL. THE VALUE IS GREATER THAN 0.014 IN SIX TO SEVEN PATIENTS OUT OF TEN PATIENTS. THE ISSUE WAS DISCOVERED IN NORMAL EYES TOO. ADDITIONAL INFORMATION RECEIVED STATES THERE WAS NO PATIENT HARM.
Remedial action
- Other