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Intacs Procedure Marker
ADDITION TECHNOLOGY, INC. · Model KV10733 · UDI-DI 00850048576032
5
510(k) clearances
22
Adverse events
6
Recalls
96
Facilities
Description
The Procedure Marker, 0.9 mm is used for marking the 1.2 mm incision and the placement marks for the 150 degree Intacs® Corneal Implants by aligning the reticle with the center mark that has been created on the cornea. This multi-functional device is also used later in the surgical procedure to align the Vacuum Centering Guide on the cornea.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
| 2010-12-23 | Aspen Surgical Products, Inc. | Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery. |
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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.