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.
What this means for you
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
- mis-labeling
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
Distributed nationwide across the United States.
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