FDA Adverse Event
Injury
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 2833671
·
Received November 12, 2012
Report
- Report Number
- 2028159-2012-01727
- Event Type
- Injury
- Date Received
- November 12, 2012
- Date of Event
- October 12, 2012
- Report Date
- October 12, 2012
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED A SYSTEM MESSAGE DISPLAYED WHEN HE INITIATED THE "MICRO FLUX" MODE DURING A VITRECTOMY AND GAS/FLUID EXCHANGE PROCEDURE. A QUESTIONNAIRE WAS RETURNED FROM THE SURGEON INDICATING THAT WHEN ASPIRATING SUB-RETINAL FLUID WITH THE CUTTER, RETINAL TISSUE INCARCERATED. THE SURGEON ATTEMPTED TO REFLUX AND GOT A SYSTEM MESSAGE INDICATING THAT THE FUNCTION WAS NOT AVAILABLE. THE SURGEON HAD TO MECHANICALLY DISENGAGE THE RETINA TISSUE. THE PT IS CURRENTLY IN THE POSTOPERATIVE PERIOD, THEREFORE THE OUTCOME OF THE EVENT IS UNK.
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 | 36 YR | Required Intervention |