FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION WITH LASER
MDR report key: 2040529
·
Received March 18, 2011
Report
- Report Number
- 2028159-2011-00247
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 16, 2011
- Report Date
- February 16, 2011
- Manufacturer
- ALCON - RIVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K063583
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. 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 · 1
A SENIOR SURGICAL TECHNICIAN REPORTED THAT THERE WERE CONTINUOUS BUBBLES IN THE IRRIGATION LINE. NO HARM OR INJURY TO THE PT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTELLATION WITH LASER | UNIT, PHACOFRAGMENTATION | HQC | ALCON - RIVINE TECHNOLOGY CENTER | CONSTELLATION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |