Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contou
Summary
The FDA issued a Class II for Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Num by Meddev Corp. Reason: Due to mislabeling of products.
Details
Source
Device Recall
External ID
Z-1745-2025
Action Date
2025-05-21
Status
Ongoing
Category
device
Product Description
Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.
Lot/Code Info: Model No LL3012; UDI code: 010081314202039917260727107228 Lot Number: 7228
Quantity Affected: 34 weights
Reason for Recall
Due to mislabeling of products
Distribution
U.S. Nationwide distribution in the states of CA, CO, CT, FL, IA, IL, MA, ME, MI, NE, NY, OH, OK, OR, SC, TX, and WV.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-12
Company
Sunnyvale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Meddev Corp has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Meddev Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Meddev Corp have FDA actions?
Meddev Corp has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1745-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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