Recall Z-1539-2013— Abbott Medical Optics, Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Medical Optics, Inc., initiated 2013-05-28, terminated 2014-11-12. FDA's recall record names no specific 510(k) clearance for this event. 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 populations.. Reason: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser..
- Recalling firm
- Abbott Medical Optics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-28
- Terminated
- 2014-11-12
- Firm location
- Milpitas, CA, United States
Product description
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 populations.
Reason for recall
Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
Data sourced from openFDA. This site is unofficial and independent of the FDA.