FDA Adverse Event
Injury
Summary report: N
COMPLETE MOISTUREPLUS
MDR report key: 883788
·
Received July 20, 2007
Report
- Report Number
- 2020664-2007-00105
- Event Type
- Injury
- Date Received
- July 20, 2007
- Report Date
- June 25, 2007
- Manufacturer
- ADVANCED MEDICAL OPTICS, INC.
- Product Code
- LPN
- Removal / Correction Number
- PENDING
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
Narratives
Additional Manufacturer Narrative · 1
BATCH RECORD REVIEW REQUESTED FROM MANUFACTURING SITE; RESULTS PENDING. AMO INITIATED AN IMMEDIATE AND VOLUNTARY RECALL OF ITS COMPLETE MOISTUREPLUS CONTACT LENS SOLUTION IN RESPONSE TO INFORMATION PROVIDED THAT DAY BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION REGARDING EYE INFECTIONS FROM ACANTHAMOEBA.
Description of Event or Problem · 1
THE CENTERS FOR DISEASE CONTROL AND PREVENTION MADE DATA AVAILABLE TO AMO SHOWING THAT IT HAD INTERVIEWED AN ADDITIONAL 24 PATIENTS WHO HAD BEEN DIAGNOSED WITH ACANTHAMOEBA INFECTIONS SINCE 2005. FURTHER DETAILS PROVIDED BY THE CDC INDICATED THAT ONE PATIENT USED LOT 35456. WE ARE ATTEMPTING TO OBTAIN FURTHER INFORMATION. ROOT CAUSE HAS NOT BEEN ESTABLISHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPLETE MOISTUREPLUS | LPN | ADVANCED MEDICAL OPTICS, INC. | NA | 35456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Other |