FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION WITH LASER
MDR report key: 1940405
·
Received December 17, 2010
Report
- Report Number
- 2028159-2010-02419
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Report Date
- November 29, 2010
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K063583
- Removal / Correction Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE IS EXPECTED TO BE RETURNED FOR IN-HOUSE EVALUATION. 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 CUSTOMER REPORTED THE PROBE WOULD NOT CUT. THERE WAS NO PT INVOLVEMENT AS THIS EVENT WAS NOTICED BY THE NURSE DURING SETUP. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTELLATION WITH LASER | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | CONSTELLATION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |