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Intacs for Keratoconus, Symmetric 0.300 mm
ADDITION TECHNOLOGY, INC. · Model ICI-300-150 · UDI-DI 00850048576124
0
510(k) clearances
335
Adverse events
3
Recalls
3
Facilities
Description
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
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 irrigate under the |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.