Ai Optics Limited · 89-08 · INDIA
For Ai Optics Limited, import alert is 89-08; country is INDIA; 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 Intraocular Lens Guides; Intraocular Lenses | Intraocular Lens Guides; Intraocular Lenses; product code is 86 H - - QL Lens, Intraocular | 86 M - - SS Folders and Injectors, Intraocular Lens (IOL); date published is 05/16/2011; address is 20 Sbi Officers Colony, 1st St , Arumbakkam, INDIA, verified against its source on 2026-09-30.
- Firm
- Ai Optics Limited 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
- INDIA verified
- Address
- 20 Sbi Officers Colony, 1st St , Arumbakkam, INDIA verified
- Date published
- 05/16/2011 verified
- Product code
- 86 H - - QL Lens, Intraocular | 86 M - - SS Folders and Injectors, Intraocular Lens (IOL) each item verified
- Product
- Intraocular Lens Guides; Intraocular Lenses | Intraocular Lens Guides; Intraocular Lenses each item verified
- FDA notes
- Class III | Class III each item verified
What the source says
Ai Optics Limited Date Published : 05/16/2011 20 Sbi Officers Colony, 1st St , Arumbakkam, INDIA
— 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 - - QL Lens, Intraocular Date Published: 05/16/2011 Desc: Intraocular Lens Guides; Intraocular Lenses Notes: Class III 86 M - - SS Folders and Injectors, Intraocular Lens (IOL) Date Published: 05/16/2011 Desc: Intraocular Lens Guides; Intraocular Lenses Notes: Class III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html