FDA Adverse Event
Injury
Summary report: N
CENTURION VISION SYSTEM
MDR report key: 3830088
·
Received May 1, 2014
Report
- Report Number
- 2028159-2014-00752
- Event Type
- Injury
- Date Received
- May 1, 2014
- Date of Event
- March 31, 2014
- Report Date
- April 4, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K121555
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT A SURGE IN VACUUM OCCURRED DURING SURGERY CAUSING A POSTERIOR CAPSULE TEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261834 | CENTURION VISION SYSTEM | PHACOFRAGMENTATIONN SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |