FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 865911
·
Received June 12, 2007
Report
- Report Number
- 3005087645-2007-00009
- Event Type
- Injury
- Date Received
- June 12, 2007
- Date of Event
- May 15, 2007
- Report Date
- June 13, 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 PT HAD A CORNEAL TRANSPLANT IN THE RIGHT EYE IN 2000. THE PT HAD BEEN WEARING THE CONTACT LENS. THE PT DEVELOPED CORNEAL ULCER IN THE RIGHT EYE AND IT WAS DIAGNOSED IN 2007. THE PT REQUIRED MEDICAL INTERVENTION WHICH INCLUDED RECEIVING FORTIFIED ANTIBIOTIC EYE DROPS. THE PATIENT'S RECOVERY WAS VERY, SLOW AND HAD PERSISTENT INFECTION. RESOLUTION WAS 100% WITH NO FURTHER ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | CONTACT LENS | LPL | SYNERGEYES, INC. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |