FDA Adverse Event
Malfunction
Summary report: N
CONSEPT QUICK NEUTRALIZING SOLUTION
MDR report key: 1592958
·
Received January 28, 2010
Report
- Report Number
- 2020664-2009-00079
- Event Type
- Malfunction
- Date Received
- January 28, 2010
- Date of Event
- September 25, 2009
- Report Date
- October 13, 2009
- Manufacturer
- ABBOTT MEDICAL OPTICS, INC.
- Product Code
- LPN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. CHEMISTRY EVAL RESULTS OF RETAINED UNIT FROM THE REPORTED LOT WERE WITHIN SPECIFICATIONS. CHEMISTRY EVAL RESULTS OF THE COMPLAINT UNIT DID NOT MEET PRODUCT SPECIFICATIONS FOR CATALASE ACTIVITY.
Description of Event or Problem · 1
OUR OFFICE IN (B) (4) REPORTED THAT A FEMALE PT EXPERIENCED OCULAR STINGING WITH EACH USE OF A NEW UNIT OF THE CONSEPT QUICK SYSTEM. THERE IS NO INDICATION THAT THE PT REQUIRED MEDICAL TREATMENT. NO ADD'L INFO IS AVAILABLE OR EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSEPT QUICK NEUTRALIZING SOLUTION | LPN | ABBOTT MEDICAL OPTICS, INC. | NA | PT0207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONSEPT QUICK DISINFECTING SOLUTION |