FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION WITH LASER
MDR report key: 2100597
·
Received May 13, 2011
Report
- Report Number
- 2028159-2011-00543
- Event Type
- Malfunction
- Date Received
- May 13, 2011
- Date of Event
- April 15, 2011
- Report Date
- April 15, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K063583
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP EXAMINED THE SYSTEM AND DUPLICATED THE PROBLEM REPORTED. THE RADIO FREQUENCY IDENTIFICATION (RFID) PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AND SENT FOR IN-HOUSE EVAL. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY (B)(4) WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A HOSP MATERIALS MGR REPORTED THAT THE LASER STOPPED FUNCTIONING AND THE INDIRECT AND ENDOPROBE WERE NOT WORKING CORRECTLY. NO HARM TO THE PT WAS REPORTED.
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 | UNK |