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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 5,767
Distribution
Part of a larger recall action
This product is one of 2 recalled by Lacrimedics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Lacrimedics Inc
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