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Intacs Corneal Implants
ADDITION TECHNOLOGY, INC. · Model ICI · UDI-DI 00866304000104
0
510(k) clearances
335
Adverse events
3
Recalls
3
Facilities
Description
An implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. The medical device is a plastic arc, of about 150 degrees, that is inserted into the cornea via an intrastromal channel. It is typically available in sizes from 0.250 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.