FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3834546
·
Received March 19, 2014
Report
- Report Number
- 2028159-2014-00447
- Event Type
- Malfunction
- Date Received
- March 19, 2014
- Date of Event
- February 20, 2014
- Report Date
- February 21, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
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 INFO BECOMES AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED, HOWEVER NONE IS EXPECTED. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT AIR DID NOT COME OUT WHEN SWITCHED TO AIR SUBSTITUTION. AIR PRESSURE WENT UP BUT AIR DID NOT COME PUT. THIS PROBLEM WAS SOLVED AFTER EXCHANGING THE TUBE. NO PT HARM WAS REPORTED. ADDITIONAL INFO WAS REQUESTED, HOWEVER NONE IS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162269 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CTR | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TPP, 25+ 5.0 CPM VALVED STD J |