Z-1744-2025Class II

Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product...

Name: Z-1744-2025 Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product...
Creator: Meddev Corp
Published: 2024-07-12
License: https://open.fda.gov/license/

Meddev Corp / initiated 2024-07-12 / Open, Classified / root cause: manufacturing process

FDA source

Meddev Corp began a recall of Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev... on 2024-07-12. FDA classified it as Class II and gives the reason as "Due to mislabeling of products". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1744-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-12
Posted: 2025-05-09
Recalling firm: Meddev Corp
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.
Product code: NCB Weights, Eyelid, Implantable
Reason for recall: Due to mislabeling of products
Root cause tag: manufacturing process
FDA 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 [email protected] 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)
Quantity in commerce: 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.
Product codes and lots: Model No LL3010; UDI code: 010081314202038217260727107227 Lot Number: 7227

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1744-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1744-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-09
Z-1745-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-09

Product code NCB

K150986Class IIContour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation / cleared 2015-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)