Abbott Recalls STAR Excimer Laser Systems Due to Power Component Failure
Abbott Medical Optics is recalling STAR Excimer Laser Systems because a power component failure can cause the lamp and illumination system to malfunction.
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 lead to harm during surgery, 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 ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450. The recall also includes STAR S2, 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 malfunction is caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
A total of 834 units were distributed worldwide, including the United States (nationwide, including Puerto Rico), Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America. There are no expiration dates for these systems. Users should contact Abbott Medical Optics for further instructions regarding the corrective action.
The recalled product
- Product
- STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, 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
- 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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