CLASS II Device recall · Reported 19 Jun 2013 · FDA Enforcement Report

Star S3 ActiveTrack Excimer System (Star S3) recalled

Abbott Medical Optics is recalling Star S3 ActiveTrack Excimer System (Star S3), distributed nationwide in the US. The recall was initiated on 28 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 0030-4864 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.

Quantity recalled1,882 total all systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1539-2013
FDA event ID: 65285
Recalling firm: Abbott Medical Optics, Milpitas, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2013
FDA classified: 12 Jun 2013
Reported: 19 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

28 May 2013	Recall initiated by company
12 Jun 2013	Classified by FDA	+15 days
19 Jun 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus. .

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.

Which lots are affected?

Model 0030-4864 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 65285

This product is part of a recall event; the main page for the event is Star S4 with Variable Spot Scanning Excimer System (Star S4) recalled.

Reported	Class	Recall	Company	Reason	Where
19 Jun 2013	CLASS II	Star S4 with Variable Spot Scanning Excimer System (Star S4) recalled	Abbott Medical Optics	Foreign Material	Nationwide
19 Jun 2013	CLASS II	Star S4 IR Excimer System (Star S4 IR) recalled by Abbott Medical Optics	Abbott Medical Optics	Foreign Material	Nationwide

More recalls from Abbott Medical Optics

All 9

Reported	Class	Recall	Company	Reason	Where
29 Apr 2015Device	CLASS II	OptiMedica Catalys Precision Laser System recalled	Abbott Medical Optics	Other	Nationwide
30 Oct 2013Device	CLASS II	STAR Excimer Laser System recalled by Abbott Medical Optics	Abbott Medical Optics	Device Malfunction	Nationwide
30 Oct 2013Device	CLASS II	STAR Excimer Laser System recalled by Abbott Medical Optics	Abbott Medical Optics	Device Malfunction	Nationwide
30 Oct 2013Device	CLASS II	STAR ActiveTrak Excimer Laser System recalled by Abbott Medical Optics	Abbott Medical Optics	Device Malfunction	Nationwide
30 Oct 2013Device	CLASS II	STAR Excimer Laser System with Variable Spot Scanning recalled	Abbott Medical Optics	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide