FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 2861592
·
Received November 28, 2012
Report
- Report Number
- 2028159-2012-01845
- Event Type
- Malfunction
- Date Received
- November 28, 2012
- Date of Event
- October 30, 2012
- Report Date
- October 30, 2012
- 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE HAS BEEN REC'D AND IN-HOUSE EVAL IS IN PROGRESS. FIVE LOT NUMBERS WERE IDENTIFIED WITH THE COMPLAINT. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE WERE FOUND DURING THE DEVICE HISTORY RECORD. THE PRODUCT WAS RELEASED ACCORDING TO THE MFR'S ACCEPTANCE CRITERIA. 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, DURING A PROCEDURE, THE NEEDLE MOVED FREELY WITH CUTTER WHEN CUTTING. THERE WAS NO PT HARM REPORTED. ADD'L INFO HAS BEEN REQUESTED.
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 | UNK | TOTAL PLUS PAK| 25G |