FDA Adverse Event
Malfunction
Summary report: N
ACCURUS 400VS
MDR report key: 2030934
·
Received March 4, 2011
Report
- Report Number
- 2028159-2011-00197
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- January 30, 2011
- Report Date
- February 2, 2011
- 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
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION REGARDING PRODUCT EVALUATION IS PENDING. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED DURING A PROCEDURE, THE SYSTEM EJECTED THE CASSETTE. THE PROCEDURE WAS COMPLETED THE SAME DAY. PATIENT IMPACT UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCURUS 400VS | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | ACCURUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |