FDA Adverse Event
Injury
Summary report: N
PRIVATE LABEL MULTIPURPOSE SOLUTION
MDR report key: 1523225
·
Received October 28, 2009
Report
- Report Number
- 2020664-2009-00066
- Event Type
- Injury
- Date Received
- October 28, 2009
- Report Date
- September 8, 2009
- Manufacturer
- ABBOTT MEDICAL OPTICS, INC.
- Product Code
- LPN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. RETAIN SAMPLE TESTING FOR MICROBIOLOGY HAS BEEN PERFORMED. TEST RESULTS WERE WITHIN SPECIFICATIONS. ROOT CAUSE HAS NOT BEEN ESTABLISHED.
Description of Event or Problem · 1
AMO RECEIVED A REPORT FROM A DISTRIBUTOR REGARDING A FEMALE CONSUMER WHO REPORTED THAT BOTH SHE AND HER SON EXPERIENCED ULCERS IN THEIR EYES WHILE USING MULTIPURPOSE SOLUTION (PRIVATE LABEL). NO ADDITIONAL INFO HAS BEEN PROVIDED. THIS REPORT IS RELATED TO MDR 202664-2009-00062. WE ARE ATTEMPTING TO OBTAIN FURTHER INFO REGARDING THE PT, HER EVENT, TREATMENT, RETRIEVAL OF THE COMPLAINT UNIT AND ATTENDING PHYSICIAN INFO TO OBTAIN PROFESSIONAL EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIVATE LABEL MULTIPURPOSE SOLUTION | LPN | ABBOTT MEDICAL OPTICS, INC. | NA | AE00210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |