FDA Adverse Event
Malfunction
Summary report: N
EVEREST LEGACY
MDR report key: 3851949
·
Received April 11, 2014
Report
- Report Number
- 2028159-2014-00601
- Event Type
- Malfunction
- Date Received
- April 11, 2014
- Date of Event
- March 13, 2014
- Report Date
- March 17, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K952213
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY A COMPANY REPRESENTATIVE AND IS IN TRANSIT TO THE MANUFACTURING SITE FOR INVESTIGATION. 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 SURGEON REPORTED THAT THERE WAS LEAKAGE FROM THE PRODUCT PRIOR TO A PROCEDURE. IT WAS NOTED THAT THERE HAD BEEN NO PROBLEM WHEN PRIMING. THE ISSUE WAS SOLVED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221252 | EVEREST LEGACY | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MICROTIP MAXVAC TIPLESS PAK |