FDA Adverse Event
Malfunction
Summary report: N
LAUREATE WORLD PHACO SYSTEM
MDR report key: 3202009
·
Received June 27, 2013
Report
- Report Number
- 2028159-2013-01130
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- May 24, 2013
- Report Date
- June 3, 2013
- 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)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THE EQUIPMENT DISPLAYED A SYSTEM MESSAGE DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. FOLLOWING A DELAY GREATER THAN 15 MINUTES, THE PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT AND A DIFFERENCE CASSETTE. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292365 | LAUREATE WORLD PHACO SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | LAUREATE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |