FDA Adverse Event
Malfunction
Summary report: N
LAUREATE WORLD PHACO SYSTEM
MDR report key: 4180304
·
Received October 15, 2014
Report
- Report Number
- 2028159-2014-01912
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 15, 2014
- Report Date
- September 15, 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
- MX
- 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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT BEFORE A VITRECTOMY PROCEDURE, THE ANTERIOR VITRECTOMY HANDPIECE DID NOT CUT. THE CASE WAS SUCCESSFULLY COMPLETED BY USING THE MANUAL MODE. THERE WAS NO HARM TO THE PATIENT. THE CUSTOMER INDICATED THAT THE VITRECTOMY PROBE HAD BEEN USED SEVERAL TIMES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654858 | LAUREATE WORLD PHACO SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | LAUREATE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | LAUREATE ANTERIOR VITRECTOMY |