Reported Oct 30, 2013 · Terminated
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is…
Abbott Medical Optics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Medical Optics, Inc. · 510 Cottonwood Dr · Milpitas, CA · 95035-7403
Is this the product you have?
- STAR Excimer Laser System with Variable Spot Scanning
- ModelSTAR S4
- Catalog Number0030-4077, 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 (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations
- Lot codes and dates
- All units of these modelsSTAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems
- Amount recalled
- 834 units in total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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