FDA Adverse Event
Other
Summary report: N
OPAQUE HERRICK LACRIMAL PLUG
MDR report key: 1883291
·
Received October 21, 2010
Report
- Report Number
- 2024818-2010-00001
- Event Type
- Other
- Date Received
- October 21, 2010
- Date of Event
- June 29, 2010
- Report Date
- October 21, 2010
- Manufacturer
- LACRIMEDICS, INC.
- Product Code
- LZU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO EVIDENCE AT THIS TIME THAT THE PLUG WAS THE CAUSE OF THE EPIPHORA AS EPIPHORA IS STILL PRESENT.
Description of Event or Problem · 1
PT HAD HERRICK PLUGS INSERTED IN LEFT AND RIGHT EYE IN 10/2002. RETURNED TO DR IN (B)(6) 2010 COMPLAINING OF EPIPHORA. IRRIGATION WAS NOT SUCCESSFUL AND PT HAD SURGERY ON RIGHT LOWER PUNCTA (B)(6) 2010; A HERRICK PLUG WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPAQUE HERRICK LACRIMAL PLUG | HERRICK PLUG | LZU | LACRIMEDICS, INC. | HP3 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention | PROZAC| NEXIUM |