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

Recall date

January 17, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0709-2022

FDA classification

Class II

Brand / firm

Lacrimedics Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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