The Recall Desk

FDA (Devices) recall action 66304

Abbott Medical Optics, Inc. recalled 4 products on 2013-10-30

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2013-10-30
Critical
0
Units
3,336

Why these products were recalled

This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).

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

1–4 of 4

  • HighFDA (Devices)··2013-10-30

    Abbott Medical Optics Recalls STAR Excimer Laser Systems Due to Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor component failure that affects the lamp and illumination system.

    Product
    STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2013-10-30

    Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor failure on the power distribution board that affects the lamp and illumination system.

    Product
    STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-10-30

    Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor failure on the AC Power Distribution PCB that affects the lamp and illumination system.

    Product
    STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-10-30

    Abbott Recalls STAR Excimer Laser Systems Due to Power Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems because a power component failure can cause the lamp and illumination system to malfunction.

    Product
    STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive…
    Category
    Distribution
    1 state