FDA Adverse Event
Injury
Summary report: N
CONSTELLATION WITH LASER
MDR report key: 2083053
·
Received May 5, 2011
Report
- Report Number
- 2028159-2011-00462
- Event Type
- Injury
- Date Received
- May 5, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 29, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K063583
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. NO SAMPLE ARE RETURNING. THE ROOT CAUSE CANNOT BE DETERMINED. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED RECEIVING A SYSTEM MESSAGE ERROR DURING A PROCEDURE. ADD'L INFO WAS RECEIVED REPORTING THE SURGEON DECIDED TO ABORT THE CASE AS THE ERROR CODE COULD NOT BE RESET. AN ADD'L PROCEDURE WAS PERFORMED THE FOLLOWING DAY TO CONCLUDE THE PROCEDURE. THE PT IS REPORTED AS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTELLATION WITH LASER | UNIT, PHACOFRAGMENTATION | HQC | ALCON - IRVINE TECHNOLOGY CENTER | CONSTELLATION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |