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 lagophthalmos, usually resulting from facial paralysis.
This recall is currently active, issued May 9, 2025. It was issued by Meddev Corp.
- Company
- Meddev Corp
- Recall Initiated
- July 12, 2024
- Posted
- May 9, 2025
- Recall Number
- Z-1745-2025
- Quantity
- 34 weights
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Due to mislabeling of products
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.
Lot / Code Info
Model No LL3012; UDI code: 010081314202039917260727107228 Lot Number: 7228
Root Cause
Process control
Action Taken
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.com An updated "URGENT: MEDICAL DEVICE RECALL" Letter was distributed to customers on 04/17/2025. Updated Customer Letter is informing customer that the potential product mix-up may include an additional product and lot number (Model Number LL3012 and Lot Number 7228)