FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 2913556
·
Received December 21, 2012
Report
- Report Number
- 2028159-2012-02030
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 30, 2012
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PROBE WAS NOT RECEIVED. TWO LOT NUMBERS WERE IDENTIFIED WITH THE COMPLAINT. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE WERE FOUND DURING THE DEVICE HISTORY RECORD (DHR) REVIEW. THE PRODUCT WAS RELEASED ACCORDING TO MANUFACTURER¿S ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED WITH THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE ¿VITREOTOM¿ REFLUXED DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |