FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3960028
·
Received May 29, 2014
Report
- Report Number
- 2028159-2014-00980
- Event Type
- Malfunction
- Date Received
- May 29, 2014
- Report Date
- May 6, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
A PRODUCT SAMPLE AND ADDITIONAL EVENT DETAILS HAVE BEEN REQUESTED FOR THIS CASE. 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 THAT THERE WERE FLUIDIC PROBLEMS DURING A RETINA PROCEDURE AND THAT EYE THE OPERATED BECAME HYPOTONIC. ADDITIONAL EVENT DETAILS PRODUCT SAMPLE HAVE BEEN REQUESTED FOR THIS REPORT FOR EVALUATION. UPON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PT HARM NOTED AND THE PROCEDURE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316168 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PAK, PRM 23 5.0 CPM |