FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3221889
·
Received July 9, 2013
Report
- Report Number
- 2028159-2013-01366
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 13, 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
- JA
- 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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT A SYSTEM MESSAGE CODE OCCURRED DURING THE SURGERY AND THE IOP (INTRAOCULAR PRESSURE) CONTROL WAS UNABLE TO BE USED DURING THE SURGERY. THE PROCEDURE WAS COMPLETED BY USING THE VITRECTOMY GAS FLUID INFUSION SET WITH NO PATIENT HARM. THE SYMPTOMS OCCURRED ON THREE CASES WITH THE SAME PRODUCT LOT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312671 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | TABLETOP-JAPAN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TOTAL PLUS PAK 25+ 5.0 CPM VALVED STD J |