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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model 0030-2450 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Abbott Medical Optics, Inc.
- Reason for Recall:
- Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Model 0030-2450 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1541-2013
Related Recalls
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
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).
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).