FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 865912
·
Received June 12, 2007
Report
- Report Number
- 3005087645-2007-00010
- Event Type
- Injury
- Date Received
- June 12, 2007
- Manufacturer
- SYNERGEYES, INC.
- Product Code
- LPL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COMPLICATION RARE BUT NOT UNKNOWN, NO EVIDENCE OF MALFUNCTION OF THE DEVICE BUT RATHER AN INHERENT RISK OF CONTACT LENS WEAR.
Description of Event or Problem · 1
DR STATED THAT THE PATIENT RECEIVED A CORNEAL ULCER WITH DIFFUSE CORNEAL EDEMA. THE PATIENT REQUIRED MEDICAL ATTENTION/INTERVENTION. THE PRACTITIONER STATED THAT MEDICAL INTERVENTION WAS REQUIRED. THE "PATIENT WAS STARTED ON ZYMAR AND CILOXAIN OINTMENT." THERE WAS A 10 DAY COARSE OF TREATMENT. THE MEDICATIONS WERE TAPERED OFF WHICH RESULTED IN RECURRENCE OF ULCER, SWITCHED TO FORTIFIED ANTIBIOTIC. THE ULCER LOCATION COINCIDED WITH THE SOFT AND RIGID GAS PERMEABLE (RGP) AREA OF THE CONTACT LENS. RESOLUTION WAS 100% FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | CONTACT LENS | LPL | SYNERGEYES, INC. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |