FDA Adverse Event
Malfunction
Summary report: N
ACCURUS 800CS
MDR report key: 2913387
·
Received January 9, 2013
Report
- Report Number
- 2028159-2013-00033
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- December 5, 2012
- Report Date
- December 10, 2012
- 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
- SD, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVAL IS IN PROGRESS. THE DEVICE HISTORY RECORDS FOR THE COMPONENT LOTS WERE REVIEWED. THE ASSOCIATED LOTS (1) WERE RELEASED BASED ON THE MFR'S ACCEPTANCE CRITERIA. UNRELATED PROCESSING ABNORMALITIES WERE FOUND DURING THE REVIEW. 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 INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT DURING A PROCEDURE, THE VITREOUS CUTTER WOULD NOT CUT. THE CASE WAS COMPLETED USING AN ALTERNATE CUTTER. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11772 | ACCURUS 800CS | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | ACCURUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25+ TOTAL PLUS PAK |