Contour Gold Eyelid Weight implants recalled for mislabeling
Meddev Corp is recalling Contour Gold Eyelid Weight implants (Model LL3010, 1.0 gm) due to mislabeling. The recall affects 34 units distributed nationwide across 17 states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall. The source text identifies only mislabeling as the defect and does not report any injuries, illnesses, or adverse events, making it a minor labeling error that falls under the Moderate category.
Plain-English summary
Meddev Corp is recalling Contour Gold Eyelid Weight implants (Model LL3010, 1.0 gm) due to product mislabeling. Lot Number 7227 (UDI code: 010081314202038217260727107227) is affected. The recalled product is designed for gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.
Approximately 34 eyelid weights were distributed nationwide in California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maine, Michigan, Nebraska, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, and West Virginia.
Patients who have received this implant or healthcare providers in the affected states who may have received the product should contact Meddev Corp to report any concerns or to verify that their product is not part of this recall. Healthcare providers should quarantine any remaining stock of Lot 7227.
The recalled product
- 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…
- Manufacturer
- Meddev Corp
- Category
- Medical Device — Eyelid implant
- Hazard
- Affected units
- 34
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model No LL3010
- UDI code: 010081314202038217260727107227 Lot Number: 7227
Distribution
Part of a larger recall action
This product is one of 2 recalled by Meddev Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Meddev Corp
See all →- ModerateContour Gold Eyelid Weight implants recalled for mislabeling
FDA (Devices) · 2025-05-21
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