FDA Adverse Event
Malfunction
Summary report: N
ALLEGRO OCULYZER
MDR report key: 6970827
·
Received October 23, 2017
Report
- Report Number
- 3003288808-2017-02276
- Event Type
- Malfunction
- Date Received
- October 23, 2017
- Date of Event
- September 26, 2017
- Report Date
- January 2, 2018
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- MXK
- PMA / PMN Number
- K071183
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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).
Additional Manufacturer Narrative · 1
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).
Description of Event or Problem · 1
A SURGEON REPORTED THE ELEVATION READINGS ARE INACCURATE AND IRRELEVANT DURING REFRACTIVE TREATMENT PLANNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 747447 | ALLEGRO OCULYZER | DEVICE, ANALYSIS, ANTERIOR SEGMENT | MXK | WAVELIGHT GMBH | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |