FDA Adverse Event
Malfunction
Summary report: N
ACCURUS 800CS
MDR report key: 1891081
·
Received October 22, 2010
Report
- Report Number
- 2028159-2010-02058
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 24, 2010
- Report Date
- September 24, 2010
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K911808
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVAL. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS, THEREFORE, UNK AT THIS TIME. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED LOW VACUUM DURING A CATARACT CASE. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCURUS 800CS | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | ACCURUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |