FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3772282
·
Received December 19, 2013
Report
- Report Number
- 2028159-2013-02393
- Event Type
- Malfunction
- Date Received
- December 19, 2013
- Report Date
- December 5, 2013
- 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
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: 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 THEATRE MANAGER REPORTED THAT DURING A VITRECTOMY THE SYSTEM LOST THE INTRAOCULAR PRESSURE (IOP) DATA ON THE TOP OF THE SURGERY SCREEN. NO ERROR MESSAGES WERE DISPLAYED. THE PATIENT WAS ON THE TABLE AND THE EYE WAS STABLE, SO THE SURGEON FINISHED THE SURGERY. NO HARM TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 667722 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | XT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |