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U.S. Department of Health and Human Services

Class 2 Device Recall UNclog Eye Mask

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 Class 2 Device Recall UNclog Eye Masksee related information
Date Initiated by FirmFebruary 08, 2024
Date PostedAugust 14, 2024
Recall Status1 Completed
Recall NumberZ-2586-2024
Recall Event ID 94929
Product Classification Pad, heating, powered - Product Code IRT
ProductBrand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
Code Information Lot Code: AG23JW24 Serial # ag22
FEI Number 3017065824
Recalling Firm/
Manufacturer		 EYE COMFORT CARE LLC
57765 Nw Wilson River Hwy
Gales Creek OR 97117-9359
For Additional Information ContactVivian Surya Buehler
+1-971-4702420
Manufacturer Reason
for Recall		Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a result of tugging and pulling and may cause a short in the heating element of the mask and could potentially cause burn injuries.
FDA Determined
Cause 2		Vendor change control
ActionBetween 02/08/2024 to 05/18/2024, the firm send via email, a Stop Sale Notice and an "Voluntary Product Recall Notice" for it UNCLOG Heated Eye Masks (Lot Model# AG23JN24) inform customers that an unauthorized material substitution was made in the manufacturing process of these masks. Additionally, it was identified that a smaller safety clip was used and could compromise the integrity of the mask. Customers are instructed to: 1. Cease Use Immediately. Stop using the UNCLOG Heated Eye Mask to avoid any potential risks. 2. Claim a replacement. The firm is committed to replacing their current masks with a new, fully tested new UNCLOG eye mask at no additional cost. Any questions or assistance, contact Vivian Surya, Founder/CEO of Eye Comfort Care LLC at 888-781-2811 or email at vivian@eyeconfortcare.com
Quantity in Commerce500
DistributionU.S. Nationwide distribution in the states of AL, AZ, CA, CT, FL, KS, KY, MA, ME, MT, NC, ND, NJ, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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