The Recall Desk
HighFDA (Devices)·Z-0708-2022·Announced 2022-03-09

OPAQUE Lacrimal Plugs recalled due to sterile pouch seal defect

Lacrimedics is recalling approximately 5,767 units of OPAQUE Lacrimal Plugs due to potential defects in the sterile pouch seal that could compromise product sterility. The affected devices were distributed nationwide and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Per the rubric, Class II recalls without reported hospitalizations score at most 3. This recall qualifies for score 3 (High) as a risk-of-harm product—a sterile medical device with compromised sterilization integrity—where no injuries have been reported.

Plain-English summary

OPAQUE Herrick Lacrimal Plugs are sterile medical devices manufactured by Lacrimedics Inc for treating dry eye disease. The devices are available in three sizes: HP3 (0.3 mm), HP5 (0.5 mm), and HP7 (0.7 mm). Approximately 5,767 units are being recalled.

The sterile pouch seal of these devices may contain channels that could affect seal integrity and potentially compromise product sterility. Lacrimedics Inc initiated this recall to address this defect.

The affected products were distributed nationwide and internationally. Specific lot numbers have been identified by Lacrimedics Inc and documented by the FDA.

The recalled product

Product
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
Manufacturer
Lacrimedics Inc
Category
Medical Device — Ophthalmic
Hazard
  • sterility-compromise
  • contamination-risk

Distribution

Distributed nationwide across the United States.

Related recalls

Same category