LZUUnclassified

Plug, Punctum

Unknown

MDR events163All time

Recalls4All time

Registered firms110Currently listed

510(k) clearances49All time

Recent MDR events

163 adverse event reports on file

Event type breakdown

Injury86

Other67

Malfunction9

Unspecified1

Most-reported manufacturers

Eagle Vision, Inc.37 Medennium, Inc.32 Oasis Medical, Inc.24 Lacrimedics, Inc.21 Medennium7 Eaglevision6 Unk5 Eaglevision, Inc.3

Recalls

4 recall events for this product code

Lacrimedics Inc
TerminatedFeb 10, 2015
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905.
Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm's data also suggests that a 4 year shelf life may not be sustained.
Z-1081-2015 · View FDA record ↗
Oasis Medical Inc
TerminatedSep 23, 2006
OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)
Labeled with an incorrect diameter
Z-1520-06 · View FDA record ↗
Lacrimedics Inc
Open, ClassifiedUnknown
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Z-0708-2022 · View FDA record ↗
Lacrimedics Inc
Open, ClassifiedUnknown
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Z-0709-2022 · View FDA record ↗

Registered firms

110 firms currently registered for this product code

510(k) clearances

49 clearances for this product code