FDA Adverse Event
Injury
Summary report: N
CONSTELLATION VISION SYSTEM
MDR report key: 3113606
·
Received May 7, 2013
Report
- Report Number
- 2028159-2013-00714
- Event Type
- Injury
- Date Received
- May 7, 2013
- Date of Event
- March 19, 2013
- Report Date
- April 11, 2013
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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 INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED DURING A PROCEDURE, THE TOUCHSCREEN OF A RETINAL SYS WAS HAVING PROBLEMS AND WAS LEAKING BALANCE SALT SOLUTION. THE CASE WAS CANCELLED. THERE WAS NO PT HARM. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200027 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CTR | B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |