Reference Source

Dream eyes · 89-08 · UNITED KINGDOM

For Dream eyes, import alert is 89-08; country is UNITED KINGDOM; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Contact Lenses & Decorative Contact Lenses; product code is 86 L - - PL Lenses, Soft Contact, Daily Wear; date published is 02/01/2019; address is Unit 4 , Building 2; Marlins Meadow , Watford, UNITED KINGDOM, verified against its source on 2026-09-30.

Firm
Dream eyes verified
Import alert
89-08
Import alert name
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country
UNITED KINGDOM verified
Address
Unit 4 , Building 2; Marlins Meadow , Watford, UNITED KINGDOM verified
Date published
02/01/2019 verified
Product code
86 L - - PL Lenses, Soft Contact, Daily Wear verified
Product
Contact Lenses & Decorative Contact Lenses verified
FDA notes
Class II Device verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Dream eyes Date Published : 02/01/2019 Unit 4 , Building 2; Marlins Meadow , Watford, UNITED KINGDOM

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 02/01/2019 Desc: Contact Lenses & Decorative Contact Lenses Notes: Class II Device

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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