Recall Z-0709-2022— Lacrimedics Inc

Name: FDA recall Z-0709-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-17

Class II · Ongoing

Class II FDA medical device recall by Lacrimedics Inc, initiated 2022-01-17. It names one FDA 510(k) clearance: K895342. Product: Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment. Reason: The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility..

Recalling firm: Lacrimedics Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-01-17
Firm location: Dupont, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K895342 — COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TESTLacrimedics, Inc.·cleared 1989-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.