Recall Z-1744-2025 ยท NCB Weights, Eyelid, Implantable
Meddev Corp
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.
| Date | May 9, 2025 (initiated Jul 12, 2024) |
| Status | Open, Classified |
| Reason | Due to mislabeling of products |
| Root cause | Process control |
| Action | On 07/12/2024, the firm sent a customer notification letter via first class mail to inform customers that the labels on the Contour Gold Eyelid Implants LL3010/Lot # 7227 potentially do not match the weight; the implants labeled LL3010 (1.0 gm) may contain LL3012 (1.2 gm). Customers are instructed to check their inventory for any/all of the affected products and to contact MedDev Corporation to request for an RGA number in or return affected products and receive replacement products. For questions/concerns contact Quality Compliance Specialist at 1-800-543-2789 or email catherine@meddev-corp |
| Quantity | 34 weights |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants Meddev Corporation, Aug 17, 2015 |