Lacrimedics Collagen Plugs recalled for potential sterility seal compromise
Lacrimedics is recalling Collagen Plugs (models CP3, CP4, CP5) due to potential seal integrity defects in sterile pouches. The seals may contain channels that could compromise sterility and allow contamination.
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: FDA Class II recall involving a sterile medical device where compromised seal integrity could lead to contamination and infection risk. No illnesses or injuries have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Lacrimedics Inc. is recalling Collagen Plugs (models CP3 0.3mm, CP4 0.4mm, and CP5 0.5mm) distributed nationwide and internationally. The recall affects 4,780 units of this sterile, prescription-only medical device used for dry eye treatment.
The sterile pouch seals may contain channels that could affect seal integrity and potentially compromise sterility. This defect could allow contamination to enter the sealed package, affecting the safety of the product.
The affected devices were distributed to numerous countries including Argentina, Belgium, Bolivia, Brazil, Switzerland, China, Colombia, Czech Republic, Germany, Ecuador, Spain, Finland, Georgia, India, Israel, Malaysia, Mexico, New Zealand, Peru, Romania, Singapore, Saudi Arabia, Turkey, Taiwan, Tanzania, and the United Kingdom. Patients and healthcare providers should discontinue use of the recalled devices immediately.
Patients currently using these plugs should consult their healthcare provider about the recall. Healthcare providers should contact Lacrimedics Inc. for information regarding replacement products or alternative treatment options.
The recalled product
- Product
- Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
- Manufacturer
- Lacrimedics Inc
- Affected units
- 4,780
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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FDA (Devices) · 2022-03-09
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FDA (Devices) · 2015-02-18
Same hazard · seal integrity
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