Z-0609-2020 Class II
FDA device recall Z-0609-2020 was initiated by Lens.com on August 14, 2018 and is designated Class II. Reason for recall: The product may be counterfeit and could have microbial issues. Affected quantity: 1,600/6-contact lens cartons.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2019
- Initiation Date
- August 14, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,600/6-contact lens cartons
Product Description
Reason for Recall
Distribution Pattern
Due to HIPAA, the firm only provided a spreadsheet that contained the first name, last initial, and zip code of each customer who received email notification of the recall. Out of the 23,444 unique names on this list (25,162 names were actually listed due to multiple consumer orders), the firm believes approximately 800 of them to have received potentially counterfeit product. The recalling firm was requested to provide a consumer spreadsheet showing the name, shipping address, and email address but declined because they thought it would be a violation of HIPAA regulations.