FDA Adverse Event
Other
Summary report: N
OXYSEPT DISINFECTING SOLUTION
MDR report key: 1592137
·
Received January 28, 2010
Report
- Report Number
- 2020664-2009-00084
- Event Type
- Other
- Date Received
- January 28, 2010
- Date of Event
- October 28, 2009
- Report Date
- October 29, 2009
- Manufacturer
- ABBOTT MEDICAL OPTICS, INC.
- Product Code
- LPN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A PATIENT REPORTED EXPERIENCING OCULAR BURNING, REDNESS, AND SWOLLEN EYE OD WITH MISUSE (FIRST-TIME USE) OF OXYSEPT DISINFECTING SOLUTION WITHOUT ADDING A NEUTRALIZING TABLET. SHE WAS UNAWARE THAT A NEUTRALIZING TABLET WAS REQUIRED, AND PERCEIVED THE PRODUCT AS BEING LIKE A MULTI-PURPOSE SOLUTION. FOLLOW UP WITH THE PATIENT THE NEXT DAY INDICATED THAT HER CONJUNCTIVA WAS ENTIRELY RED. SHE SOUGHT TREATMENT FROM HER DOCTOR WHO DIAGNOSED CHEMICAL CONJUNCTIVITIS AND A SUBCONJUNCTIVAL HEMORRHAGE OD, PRESCRIBED ERYTHROMYCIN OINTMENT, AND INSTRUCTED THE PATIENT TO CONTINUE TO RINSE HER EYE WITH SALINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXYSEPT DISINFECTING SOLUTION | LPN | ABBOTT MEDICAL OPTICS, INC. | NA | ZC03207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |