FDA Adverse Event
Injury
Summary report: N
AIR OPTIX NIGHT & DAY AQUA
MDR report key: 2130422
·
Received June 14, 2011
Report
- Report Number
- 9681121-2011-00020
- Event Type
- Injury
- Date Received
- June 14, 2011
- Report Date
- May 18, 2011
- Manufacturer
- PT CIBA VISION BATAM
- Product Code
- LPM
- PMA / PMN Number
- P010019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THIS IS THE FIRST REPORT INVOLVING TWO PATIENTS EXPERIENCING MICROBIAL KERATITIS. REFER TO MEDWATCH 9681121-2011-00021 FOR A DESCRIPTION OF THE SECOND REPORT. IT WAS REPORTED BY THE EYE CARE PROFESSIONAL THAT TWO PATIENTS EXPERIENCED MICROBIAL KERATITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. UPON RECEIPT OF ADDITIONAL INFORMATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION, A FOLLOW-UP REPORT WILL BE FILED. THIS EVENT IS BEING REPORTED DUE TO LACK OF INFORMATION RECEIVED REGARDING THE PATIENT'S TREATMENT AND EVENT RESOLUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIR OPTIX NIGHT & DAY AQUA | LENSES, SOFT CONTACT, EXTENDED WEAR | LPM | PT CIBA VISION BATAM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |