Reference Source

Uniqso Holdings Sdn Bhd · 89-08 · MALAYSIA

For Uniqso Holdings Sdn Bhd, import alert is 89-08; country is MALAYSIA; 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 | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses; product code is 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort; date published is 02/03/2016; address is Jalan Balakong Batu , 1/2 , Cheras, Selangor MALAYSIA, verified against its source on 2026-09-30.

Firm
Uniqso Holdings Sdn Bhd 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
MALAYSIA verified
Address
Jalan Balakong Batu , 1/2 , Cheras, Selangor MALAYSIA verified
Date published
02/03/2016 verified
Product code
86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort each item verified
Product
Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses each item verified
FDA notes
2/3/2016 verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Uniqso Holdings Sdn Bhd Date Published : 02/03/2016 Jalan Balakong Batu , 1/2 , Cheras, Selangor MALAYSIA

— 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 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 02/03/2016 Desc: Contact lenses 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 02/03/2016 Desc: Contact lenses 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 02/03/2016 Desc: Contact lenses 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 02/03/2016 Desc: Contact lenses 86 M - - VN Lens, Contact (Disposable) Date Published: 02/03/2016 Desc: Contact lenses 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 01/30/2019 Desc: Contact lenses Notes: 2/3/2016 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 02/03/2016 Desc: Contact lenses 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 02/03/2016 Desc: Contact lenses

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

Source

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