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Ambler Surgical
AMBLER SURGICAL CORP. · Model Ambler Toric Intra-op axis marker II · UDI-DI 00190660102968
HMR
Prescription
5
510(k) clearances
21
Adverse events
6
Recalls
96
Facilities
Description
Ambler Toric Intra-op axis marker II, 4 7/8'', two 2.0mm marking blades, cutouts on the two 180 degrees positions for easy alignment, round handle, titanium
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.