Recall Z-0046-2014— Abbott Medical Optics, Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Medical Optics, Inc., initiated 2013-09-16, terminated 2014-11-12. FDA's recall record names no specific 510(k) clearance for this event. 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 keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.. Reason: 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)..
- Recalling firm
- Abbott Medical Optics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-16
- Terminated
- 2014-11-12
- Firm location
- Milpitas, CA, United States
Product description
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 keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.