Device 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.
Z-1744-2025
Product summary
- Firm
- Meddev Corp
- Event
- Event 96551
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34 weights
- Official record key
device-enforcement:Z-1744-2025
Official wording
Reason: Due to mislabeling of products
Code information: Model No LL3010; UDI code: 010081314202038217260727107227 Lot Number: 7227
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
mislabeling