FDA Adverse Event
Malfunction
Summary report: N
CONSEPT 1 STEP NEUTRALIZING TABLETS
MDR report key: 2545734
·
Received April 29, 2010
Report
- Report Number
- 2020664-2008-00081
- Event Type
- Malfunction
- Date Received
- April 29, 2010
- Date of Event
- April 16, 2008
- Report Date
- May 22, 2008
- Manufacturer
- ABBOTT MEDICAL OPTICS, INC.
- Product Code
- LPN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONSUMER RETURNED HIS LENS CASE WITH SOLUTION IN IT. THE SOLUTION WAS 1% HYDROGEN PEROXIDE. THE CONSUMER'S NEUTRALIZING TABLETS WERE FOUND TO MEET SPECS. THE ROOT CAUSE HAS NOT BEEN ESTABLISHED.
Description of Event or Problem · 1
OUR OFFICE IN (B)(4) REPORTED MALE PT EXPERIENCED EYE PAIN AFTER WEARING LENSES THAT HAD BEEN DISINFECTED/NEUTRALIZED WITH CONSEPT 1STEP. WHEN HE TRIED THE PRODUCT AGAIN, HE HAD NO FURTHER PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSEPT 1 STEP NEUTRALIZING TABLETS | LPN | ABBOTT MEDICAL OPTICS, INC. | NA | 16462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | VENTED CONTACT LENS CASE| CONSEPT 1 STEP DISINFECTING SOLUTION |