FDA-Device2022-03-09Class II

Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

Lacrimedics Inc
Hazard

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

Sold states
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
Affected count
4780 units
Manufactured in
2620 Williamson Pl Ste 113, Dupont, WA, United States
Products
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0709-2022

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