FDA Adverse Event
Malfunction
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3181943
·
Received June 17, 2013
Report
- Report Number
- 2028159-2013-01166
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 20, 2013
- Report Date
- May 22, 2013
- Manufacturer
- ALCON - IRVING TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE HAS BEEN REC'D, BUT HAS NOT YET BEEN EVALUATED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT A SYS MESSAGE DISPLAYED 30 MINUTES AFTER INFUSION MODE WAS TURNED ON DURING SURGERY. IOP (INTRAOCULAR PRESSURE) CONTROL WAS UNABLE TO BE USED AT THE SAME TIME. THE CASE WAS ABLE TO PROCEED EVEN THOUGH IOP CONTROL WAS NOT RECOVERED, HOWEVER, THE SURGEON FELT THAT IOP WAS MORE UNSTABLE THAN WHEN USING IOP CONTROL. THE CASE WAS COMPLETED WITH THE SAME PRODUCT WITHOUT PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273523 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVING TECHNOLOGY CTR | LXT - JAPAN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TOTAL PLUS PAK 25+ 5.0 CPM VALVED STD J |