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 AC Power Distribution PCB 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 is classified as FDA Class II. The rubric assigns a score of 3 (High) to risk-of-harm products where injury has not yet been reported, as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
Abbott Medical Optics, Inc. is recalling the STAR Excimer Laser System, Model STAR S4 IR, Catalog Number 0030-4864. The recall also covers all units of the STAR S2 Excimer Laser System, STAR S3 ActiveTrak, STAR S4 with Variable Spot Scanning, and STAR S41R models. These devices are indicated for laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery.
The recall is being conducted to address an identified failure of the lamp and illumination system within the laser unit. This failure is caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). The agency classifies this recall as Class II.
A total of 834 units are affected by this recall. The devices 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. There are no expiration dates for the STAR Excimer Laser Systems.
The recalled product
- Product
- STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, 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.
- 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
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