FDA Adverse Event
Malfunction
Summary report: N
CONSEPT 1-STEP NEUTRALIZING TABLETS
MDR report key: 2545709
·
Received January 28, 2010
Report
- Report Number
- 2020664-2009-00092
- Event Type
- Malfunction
- Date Received
- January 28, 2010
- Date of Event
- October 19, 2009
- Report Date
- November 15, 2009
- Manufacturer
- ABBOTT MEDICAL OPTICS, INC.
- Product Code
- LPN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CHEMISTRY TESTING OF THE COMPLAINT UNIT TABLETS WAS PERFORMED; THE CATALASE ACTIVITY OF THE NEUTRALIZATION TEST RESULTS DID NOT MEET SHELF LIFE SPECS. RETAIN SAMPLE TESTING FOR CHEMISTRY HAS BEEN PERFORMED. TEST RESULTS WERE WITHIN SPECS. A REVIEW OF THE MFG BATCH RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND THE PRODUCT MET ALL SPECS.
Description of Event or Problem · 1
OUR OFFICE IN (B)(4) REPORTED A MALE CONSUMER EXPERIENCED A STINGING SENSATION, AFTER USE OF CONSEPT 1-STEP (HYDROGEN PEROXIDE) DISINFECTING/NEUTRALIZING SYSTEM. THE EVENT BEGAN WITH THE USE OF THE SECOND SHEET OF NEUTRALIZING TABLETS. THE PT'S EVENT RESOLVED WITHOUT MEDICAL TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSEPT 1-STEP NEUTRALIZING TABLETS | LPN | ABBOTT MEDICAL OPTICS, INC. | NA | 25696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONSEPT 1-STEP DISINFECTING SOLUTION| CONSEPT 1-STEP LENS CARE |