Reported Jun 19, 2013 · Terminated
STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive…
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 S4 with Variable Spot Scanning Excimer System (STAR S4) 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.
- Lot codes and dates
- Model 0030-4077 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
- Amount recalled
- 1,882 - total all systems
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
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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