Contour Gold Eyelid Weight implants recalled for mislabeling
Meddev Corp is recalling Contour Gold Eyelid Weight implants (Model LL3012) due to mislabeling. Thirty-four weights distributed nationwide are affected.
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: FDA Class II recall for labeling defect with no reported injuries or illnesses. Mislabeling of a medical device without evidence of harm or adverse clinical consequence meets the criteria for Moderate severity.
Plain-English summary
Meddev Corp is recalling Contour Gold Eyelid Weight implants, Model No. LL3012, 1.2 gm, due to product mislabeling. The affected lot (Lot Number 7228, UDI code: 010081314202039917260727107228) comprises 34 eyelid weights.
The Contour Gold Eyelid Weight is designed for gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis. The implants were distributed nationwide to healthcare facilities 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 who have this product in stock should contact Meddev Corp for further guidance. The FDA has classified this as a Class II recall.
The recalled product
- Product
- 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…
- Manufacturer
- Meddev Corp
- 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 LL3012
- UDI code: 010081314202039917260727107228 Lot Number: 7228
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
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