Recall Z-1744-2025— Meddev Corp

Name: FDA recall Z-1744-2025
Creator: U.S. Food and Drug Administration
Published: 2024-07-12

Class II · Ongoing

Class II FDA medical device recall by Meddev Corp, initiated 2024-07-12. It names one FDA 510(k) clearance: K150986. Product: Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.. Reason: Due to mislabeling of products.

Recalling firm: Meddev Corp
Classification: Class II
Status: Ongoing
Initiated: 2024-07-12
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K150986 — Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation·cleared 2015-08-17

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

Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.

Reason for recall

Due to mislabeling of products

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