FDA Adverse Event
Injury
Summary report: N
ACUVUE OASYS
MDR report key: 1143683
·
Received August 29, 2008
Report
- Report Number
- 1033553-2008-00105
- Event Type
- Injury
- Date Received
- August 29, 2008
- Report Date
- August 30, 2008
- Manufacturer
- VISTAKON
- Product Code
- LPL
- PMA / PMN Number
- P040045
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE LABELING SINGLE USE OR REUSE. NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
FOREIGN AFFILIATE REPORTS PHYSICIAN REPORTED A "CORNEAL ABSCESS" OD FOR A WEARER OF ACUVUE OASYS. THE PATIENT HAS WORN OASYS SINCE 08 AND HAD NO REACTION BEFORE. THE DOCTOR HAS PRESCRIBED TOBREX AND CILOXAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. "CORNEAL ABCESS" HAS OFTEN BEEN USED SYNONYMOUSLY WITH CORNEAL ULCER BY PRACTITIONERS IN ANOTHER COUNTRY. CLARIFICATION HAS BEEN REQUESTED FROM THE REPORTING PHYSICIAN. PRODUCT INFORMATION WAS NOT RECEIVED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUVUE OASYS | SOFT CONTACT LENS | LPL | VISTAKON | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |