Meddev Corp recalls Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL…
Reason for recall
Due to mislabeling of products
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 paralysisUDI codeAffected lot7227
What the firm is doing
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)
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1744-2025
- FDA 510(k) clearance · K150986The device's official FDA premarket clearance record
- FDA device classification · NCBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.5700The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Meddev CorpSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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