The Recall Desk

FDA (Devices) recall action 65285

Abbott Medical Optics, Inc. recalled 3 products on 2013-06-19

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2013-06-19
Critical
0
Units
5,646

Why these products were recalled

Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2013-06-19

    Abbott STAR S4 Excimer Laser System Recalled for Potential Inadvertent Firing

    Abbott Medical Optics is recalling STAR S4 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.

    Product
    STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-06-19

    Abbott STAR S4 IR Excimer Laser System Recalled for Firing Risk

    Abbott Medical Optics is recalling 1,882 STAR S4 IR Excimer Laser Systems worldwide due to an unlikely potential for inadvertent laser firing under specific conditions.

    Product
    STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-06-19

    Abbott STAR S3 Excimer Laser System Recalled for Firing Risk

    Abbott Medical Optics is recalling STAR S3 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.

    Product
    STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient…
    Category
    Distribution
    1 state