Abbott Medical Optics Recalls STAR Excimer Laser Systems Due to Component Failure
Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor component failure that affects the lamp and illumination system.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a component failure could impact surgical procedures, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Abbott Medical Optics, Inc. is recalling the STAR Excimer Laser System with Variable Spot Scanning, Model STAR S4, Catalog Number 0030-4077. The recall also includes STAR S2 Excimer Laser Systems, STAR S3 ActiveTrak, and STAR S41R models. A total of 834 units were distributed worldwide, including the United States, Puerto Rico, Canada, and various regions in Asia, Europe, Africa, the Middle East, Japan, and Latin America.
The recall is being conducted to address an identified failure of the lamp and illumination system within the laser unit. This issue is caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). The devices are indicated for laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery.
Healthcare providers and facilities using these devices should contact Abbott Medical Optics for further instructions regarding the corrective action. The source text does not specify a specific action for consumers, as these are professional medical devices.
The recalled product
- Product
- STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, 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),
- Manufacturer
- Abbott Medical Optics, Inc.
- Affected units
- 834
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- All units of these models: STAR 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.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Abbott Medical Optics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Abbott Medical Optics, Inc.
See all →- HighAbbott OptiMedica Catalys Precision Laser System Recalled for Corneal Scoring Risk
FDA (Devices) · 2015-04-29
- HighAbbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure
FDA (Devices) · 2013-10-30
- HighAbbott Recalls STAR Excimer Laser Systems Due to Power Component Failure
FDA (Devices) · 2013-10-30
- ModerateAbbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure
FDA (Devices) · 2013-10-30
- HighAbbott Sovereign Compact Phacoemulsification System Recalled for Vacuum Loss Risk
FDA (Devices) · 2013-07-17
Same hazard · component failure
See all →- ModerateSpacelabs Xhibit Central Station Recalled for DisplayPort Audio/Video Failures
FDA (Devices) · 2026-08-19
- High
- SevereKawasaki Teryx4 and Teryx5 H2 drive converter sheaves can break
CPSC · 2026-06-11
- HighOlympus Thunderbeat II Shears Ultrasonic Mode distal tip detachment risk
FDA (Devices) · 2026-04-29
- HighArch Studio tea kettle handles can detach when the kettle heats
CPSC · 2026-04-16