FDA Adverse Event
Injury
Summary report: N
ADVANCED MEDICAL OPTICS, INC.
MDR report key: 788567
·
Received November 30, 2006
Report
- Report Number
- MW1041222
- Event Type
- Injury
- Date Received
- November 30, 2006
- Date of Event
- November 18, 2006
- Report Date
- November 29, 2006
- Manufacturer
- ADVANCED MEDICAL OPTICS, INC.
- Product Code
- LPN
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
AMO COMPLETE MOISTURE PLUS. I USED THAT CONTACT SOLUTION AND I GOT AN EYE INFECTION -CONJUNCTIVITIS- IN BOTH EYES. MY EYES WERE RED SINCE THE BEGINNING OF NOVEMBER, BUT THE PAIN WAS ON AND OFF UNTIL THE PERIOD 11/16-11/18 WHERE IT GOT SO PAINFUL THAT I COULD NOT OPEN MY EYES. I WENT TO THE EMERGENCY ROOM AND THEY DIAGNOSED ME WITH CONJUNCTIVITIS. I WAS GIVEN 0.3% OFLOXACIN FOR IT. I TOOK THE EYE DROPS AS PRESCRIBED -EVERY 2 HOURS FOR THE FIRST 2 DAYS AND DAILY AFTERWARDS FOR 5 MORE DAYS. MY EYES HAVE CLEARED UP AND I HAVE RESUMED WEARING CONTACT LENS AGAIN. I READ THE RECALL OF THE SOLUTION AND MY BOTTLE NUMBER MATCHES THE LOT NUMBER BEING RECALLED -ZB02799-.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCED MEDICAL OPTICS, INC. | MULTI-PURPOSE CONTACT SOLUTION | LPN | ADVANCED MEDICAL OPTICS, INC. | * | ZB02799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Hospitalization |