Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight,…
Meddev Corp · Due to mislabeling of products
Open FDA's page for this record- Cfres ID
- 213143
- Product res number
- Z-1744-2025
- Event date initiated
- 2024-07-12
- Event date posted
- 2025-05-09
- Recall status
- Open, Classified
- Res event number
- 96551
- Product code
- NCB
- Code info
- Model No LL3010; UDI code: 010081314202038217260727107227 Lot Number: 7227
- Firm FEI number
- 2921577
- Recalling firm
- Meddev Corp
- Address 1
- 730 N Pastoria Ave
- City
- Sunnyvale
- State
- CA
- Postal code
- 94085-3522
- Additional info contact
- Catherine Leong +1-408-7309702
- Reason for recall
- Due to mislabeling of products
- Root cause description
- Process control
- Product quantity
- 34 weights
- 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.
- Product description
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.
- 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.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)
- K numbers
- K150986
- Harmonized identifiers (openFDA)
- Device name
- Weights, Eyelid, Implantable
- Medical specialty description
- Ophthalmic
- Regulation number
- 886.5700
- Device class
- 2
- K number
- K203569
- Registration number
- 9615745, 3002991496, 3004467263
- FEI number
- 3000314405, 3002991496, 3004467263