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Ambler Surgical

AMBLER SURGICAL CORP. · Model Whitehouse gravity axis marker · UDI-DI 00190660217716

HMR Prescription
5
510(k) clearances
21
Adverse events
6
Recalls
96
Facilities

Description

Whitehouse gravity axis marker, 6 1/4'', angled, marks the limbus at 3, 6 and 9 o'clock to avoid the effect of cyclotortion, hind weight position assures excellent visualization and balance, inner diameter 11mm, outer diameter 13mm

Recalls

DateFirmReason
2010-12-23Aspen 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.
2010-12-23Aspen 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.
2010-12-23Aspen 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.
2010-12-23Aspen 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.
2010-12-23Aspen 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.
2010-12-23Aspen 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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Data 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.