FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION WITH LASER
MDR report key: 2072384
·
Received April 8, 2011
Report
- Report Number
- 2028159-2011-00352
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 9, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K063583
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT DURING SURGERY, THE VERTICAL SCISSORS TIP CAME OFF A PNEUMATIC HANDPIECE WHILE IN THE PT'S EYE. THERE HAVE BEEN REPORTS OF ANY PT HARM ASSOCIATED WITH THIS EVENT. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTELLATION WITH LASER | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CTR | CONSTELLATION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONSTELLATION SYSTEM |