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Lacrimedics, Inc.

United StatesFDA applicant, unverified

Devices
12
FDA recalls
32 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Lacrimedics, Inc. makes

Lacrimedics, Inc. manufactures lacrimal plugs and diagnostic tools for assessing tear drainage, including opaque and absorbable punctum plugs (e.g., Herrick plugs in 0.3mm, 0.5mm, and 0.7mm sizes), collagen implants for lacrimal efficiency testing, and a focometer for measuring tear flow. Their products also include branded punctum plugs like the LacriPro and Collasyn, designed to treat conditions such as dry eye by blocking or modulating the lacrimal drainage system.

The company’s devices are classified under FDA Class II and unclassified (U) categories, with most authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry, reflecting their regulatory clearance status. Lacrimedics, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

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FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 3 recalls initiated by Lacrimedics, Inc., the earliest on 2014-11-26 and the most recent on 2022-01-17. By recorded status: 2 ongoing and 1 terminated. The reasons filed fall into these groups: sterility or contamination, packaging and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 2
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2022

    • 17 Jan 2022 Z-0708-2022 Class II Ongoing The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. Distribution: Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN,…
      Full distribution text Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN, IL, MY, MX, NZ, PE, RO, SG, SA, TR, TW, TZ, UK
      Submission number: K021831
    • 17 Jan 2022 Z-0709-2022 Class II Ongoing The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. Distribution: Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN,…
      Full distribution text Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN, IL, MY, MX, NZ, PE, RO, SG, SA, TR, TW, TZ, UK
      Submission number: K895342

  • 2014

    • 26 Nov 2014 Z-1081-2015 Class III Terminated 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. Distribution: Worldwide Distribution-US (nationwide) including the states of AR, CA, FL, ID, IL, KS, MA, MI, NC, NJ, NY, OR, PA, and…
      Full distribution text Worldwide Distribution-US (nationwide) including the states of AR, CA, FL, ID, IL, KS, MA, MI, NC, NJ, NY, OR, PA, and TX and to the countries of Australia, Brazil, Czech Republic, France, Ireland, Mexico, Peru, Switzerland, and United Kingdom.
      Submission number: K140026

Frequently asked questions

How many devices does Lacrimedics, Inc. have in the registry?

The registry currently lists 12 devices for Lacrimedics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Lacrimedics, Inc.'s devices?

Among its 12 most recently registered devices, Lacrimedics, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Lacrimedics, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Lacrimedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Lacrimedics, Inc.?

FDA recall records list 3 recalls initiated by Lacrimedics, Inc., the most recent initiated on 17 Jan 2022. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Lacrimedics, Inc. in the registry?

The most recently registered devices listed for Lacrimedics, Inc. include OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM, OPAQUE HERRICK LACRIMAL PLUG, LACRIMAL EFFICIENCY TEST (TM) and HERRICK ULTIMATE PUNCTUM PLUG.

Generated automatically from registry data and not verified by a human reviewer.