FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYETM
MDR report key: 4173864
·
Received August 11, 2014
Report
- Report Number
- 2028159-2014-01470
- Event Type
- Malfunction
- Date Received
- August 11, 2014
- Date of Event
- July 9, 2014
- Report Date
- July 11, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE FOOT PEDAL WAS LOOSE BEFORE A VITRECTOMY PROCEDURE. THERE WAS NO PT INVOLVEMENT. THE CASE WAS COMPLETED WITH AN ALTERNATE SYSTEM. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 476281 | CONSTELLATION VISION SYETM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CTR | LXT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |