FDA Adverse Event
Malfunction
Summary report: N
CONSEPT 1 STEP NEUTRALIZING TABLETS
MDR report key: 1672875
·
Received April 29, 2010
Report
- Report Number
- 2020664-2010-00013
- Event Type
- Malfunction
- Date Received
- April 29, 2010
- Date of Event
- January 5, 2010
- Report Date
- January 29, 2010
- Manufacturer
- ABBOTT MEDICAL OPTICS, INC.
- Product Code
- LPN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE NEUTRALIZATION TEST WAS PERFORMED USING THE RETURNED SAMPLE. THE TABLETS DID NOT MEET SHELF LIFE SPECS. RETAINED SAMPLES FROM THE SAME LOT MET SHELF LIFE SPECS. THE ROOT CAUSE HAS NOT BEEN ESTABLISHED.
Description of Event or Problem · 1
OUR OFFICE IN (B) (4) REPORTED A FEMALE CONSUMER EXPERIENCED OCULAR REDNESS AND STINGING AFTER USING CONSEPT 1 STEP DISINFECTING/NEUTRALIZING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSEPT 1 STEP NEUTRALIZING TABLETS | LPN | ABBOTT MEDICAL OPTICS, INC. | NA | 24457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONSEPT 1 STEP DISINFECTING SOLUTION |