FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3915603
·
Received June 11, 2014
Report
- Report Number
- 2028159-2014-01109
- Event Type
- Malfunction
- Date Received
- June 11, 2014
- Date of Event
- January 1, 2014
- Report Date
- May 15, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
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. A SAMPLE HAS BEEN RECEIVED BUT HAS NOT BEEN EVALUATED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 06/13/2014. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE CUTTER WOULD NOT WORK AFTER SWITCHING MODES FROM "CORE TO SHAVE". THE PROBLEM WAS RESOLVED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343729 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CTR | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0.9, COMBINED PAK| 23 GAUGE 5000 CUTS PER MINUTE |