FDA Adverse Event
Injury
Summary report: N
PROSHIELD
MDR report key: 823069
·
Received March 2, 2007
Report
- Report Number
- 1610287-2007-00009
- Event Type
- Injury
- Date Received
- March 2, 2007
- Report Date
- February 2, 2007
- Manufacturer
- ALCON LABORATORIES, INC., OASIS
- Product Code
- MOE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE DETERMINATION IS IN PROGRESS.
Description of Event or Problem · 1
A SURGEON REPORTS DIFFICULTY WITH THE COLLAGEN CORNEAL SHIELD. DURING SURGERY, THE SHIELD WAS SOAKED IN A TOPICAL ANTIBIOTIC WITH A STEROID, AND THEN PLACED ON THE CORNEA. (THE PATIENT WAS BEING TREATED WITH A HYPER OSMOTIC TREATMENT.) THE PATIENT DEVELOPED CORNEAL EDEMA WHICH HAS LASTED FOR ONE MONTH. THE SURGEON HAD TO PHYSICALLY REMOVE THE CORNEAL SHIELD FROM THE PATIENT'S EYE. THE PATIENT IS EXPERIENCING POOR VISION AND A FIXED PUPIL. THE PATIENT STATED SHE FELT LIKE THERE WAS A FOREIGN BODY IN HER EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSHIELD | COLLAGEN CORNEAL SHIELD | MOE | ALCON LABORATORIES, INC., OASIS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |