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Ambler Surgical

AMBLER SURGICAL CORP. · Model Bores low-profile optic zone marker · UDI-DI 00190660103491

HMR Prescription
5
510(k) clearances
18
Adverse events
6
Recalls
96
Facilities

Description

Bores low-profile optic zone marker, 4 1/8'', double-ended, 8.0mm/9.0mm diameter, 1.65mm ring height, round handle

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.