Home › Device types › LQE
Implant, Corneal, Refractive
FDA product code LQE · Class 3 · Unknown
18
Registered devices
335
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
Intacs for Keratoconus, Symmetric 0.400 mm — ADDITION TECHNOLOGY, INC.Intacs for Keratoconus, Asymmetric 0.210/0.400 mm — ADDITION TECHNOLOGY, INC.Intacs Corneal Implants — ADDITION TECHNOLOGY, INC.Intacs for Keratoconus, Symmetric 0.300 mm — ADDITION TECHNOLOGY, INC.KAMRA inlay — Bausch & Lomb IncorporatedIntacs for Keratoconus, Symmetric 0.250 mm — ADDITION TECHNOLOGY, INC.Inlay Inserter Chuck Handle — REVISION OPTICS, INC.KAMRA inlay — Bausch & Lomb IncorporatedRaindrop Near Vision Inlay — REVISION OPTICS, INC.Intacs for Myopia, Symmetric 0.300 mm — ADDITION TECHNOLOGY, INC.Intacs for Myopia, Symmetric 0.250 mm — ADDITION TECHNOLOGY, INC.Intacs for Keratoconus, Symmetric 0.450 mm — ADDITION TECHNOLOGY, INC.Intacs for Myopia, Symmetric 0.350 mm — ADDITION TECHNOLOGY, INC.Intacs for Keratoconus, Asymmetric 0.210/0.350 mm — ADDITION TECHNOLOGY, INC.Intacs for Keratoconus, Asymmetric 0.210/0.450 mm — ADDITION TECHNOLOGY, INC.Intacs for Keratoconus, Symmetric 0.210 mm — ADDITION TECHNOLOGY, INC.Intacs for Keratoconus, Symmetric 0.350 mm — ADDITION TECHNOLOGY, INC.KAMRA inlay — Bausch & Lomb Incorporated
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-13 | RVO 2.0, INC | During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device. |
| 2017-02-07 | Revision Optics Inc | ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only Balanced Salt Solution (BSS) may be used to |
| 2016-02-11 | AcuFocus, Inc. | AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. |
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