FDA Adverse Event
Malfunction
Summary report: N
LAUREATE WORLD PHACO SYSTEM
MDR report key: 3964382
·
Received June 19, 2014
Report
- Report Number
- 2028159-2014-01159
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 21, 2014
- Report Date
- May 21, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(6). THIS REPORT WAS MAILED TO FDA ON: 06/20/2014. THE MANUFACTURER (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THERE WAS POOR ASPIRATION DURING A SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME EQUIPMENT AND ACCESSORIES. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359448 | LAUREATE WORLD PHACO SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | LAUREATE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INFINITI ULTRASOUND HANDPIECE |