FDA Adverse Event
Injury
Summary report: N
SUPER EAGLE PUNCTUM PLUG
MDR report key: 1712859
·
Received June 1, 2010
Report
- Report Number
- 1034718-2010-00002
- Event Type
- Injury
- Date Received
- June 1, 2010
- Date of Event
- May 18, 2010
- Report Date
- June 1, 2010
- Manufacturer
- EAGLE VISION, INC.
- Product Code
- LZU
- PMA / PMN Number
- K991130
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THERE HAS NOT BEEN A FOLLOW UP VISIT WITH THE PATIENT AND NO ADDITIONAL INFORMATION IS EXPECTED.
Description of Event or Problem · 1
THE PATIENT HAD SUPER EAGLE PUNCTUM PLUGS INSERTED IN BOTH EYES FOR DRY EYE SYNDROME ON (B) (6) 2010. ON (B) (6) 2010, THE PATIENT NOTED THE LOSS OF THE PLUG AND DURING FOLLOW-UP EXAM, A GRANULOMA WAS PROTRUDING FROM THE PUNCTUM IN ONE EYE. THE PLUG IN THE OTHER EYE APPEARS TO BE STABLE AND WELL TOLERATED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPER EAGLE PUNCTUM PLUG | PUNCTUM PLUG | LZU | EAGLE VISION, INC. | 75082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |