FDA Adverse Event
Injury
Summary report: N
AIR OPTIX AQUA
MDR report key: 1940322
·
Received December 17, 2010
Report
- Report Number
- 9681121-2010-00057
- Event Type
- Injury
- Date Received
- December 17, 2010
- Report Date
- November 21, 2010
- Manufacturer
- PT CIBA VISION BATAM
- Product Code
- LPM
- PMA / PMN Number
- P010019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A F/U MEDWATCH WILL BE FILED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PT THAT SHE EXPERIENCED PINK EYE SYMPTOMS THAT CAUSED MANY EYE INFECTIONS. ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIR OPTIX AQUA | LENSES, SOFT CONTACT, EXTENDED WEAR | LPM | PT CIBA VISION BATAM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |