Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure
Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor failure on the power distribution board that affects the lamp and illumination system.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a component failure without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Abbott Medical Optics, Inc. is recalling the STAR Excimer Laser System, Model STAR S2, Catalog Number 0030-1479. The product is manufactured and distributed by AMO Manufacturing USA, LLC, in Milpitas, California. These systems are indicated for laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
The recall addresses 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 recall covers 834 units in total, including the STAR S2 Excimer Laser System, STAR S3 ActiveTrak, STAR S4 with Variable Spot Scanning, and STAR S41R models. There are no expiration dates for these systems.
The affected units were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as countries in Asia Pacific, Canada, Europe, Africa, the Middle East, Japan, and Latin America. Users of these devices should contact Abbott Medical Optics for further instructions regarding the corrective action.
The recalled product
- Product
- STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, 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 keratecto
- Manufacturer
- Abbott Medical Optics, Inc.
- Hazard
- 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.
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