Ai Optics Limited · 89-08 · INDIA
For Ai Optics Limited · 89-08 · INDIA, import alert is 89-08; 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)"; country is INDIA; 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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