FDA Adverse Event
Injury
Summary report: N
HERRICK LACRIMAL PLUG
MDR report key: 361085
·
Received November 9, 2001
Report
- Report Number
- 2024818-2001-00001
- Event Type
- Injury
- Date Received
- November 9, 2001
- Date of Event
- February 1, 2000
- Report Date
- October 19, 2001
- Manufacturer
- LACRIMEDICS, INC.
- Product Code
- LZU
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HERRICK LACRIMAL PLUGS ALLEGEDLY INSTALLED IN 1999. PATIENT WAS EXPERIENCING EPIPHORA AND WAS REFERRED TO AN OCULOPLAST. THE OCULOPLAST MADE REPEATED ATTEMPTS TO IRRIGATE OUT THE PLUGS WITHOUT APPARENT SUCCESS. A DCR WAS PERFORMED. NO PLUG WAS RECOVERED BUT SEVERE SCARRING OF THE INFERIOR CANALICULUS WAS NOTED BY THE OCULOPLAST. THE CANALICULUS WAS SUBSEQUENTLY DILATED AND INTUBATED WITH SILICONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50082 | HERRICK LACRIMAL PLUG | INTRACANALICULAR PLUG | LZU | LACRIMEDICS, INC. | HLP5 | 12199804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |