Abbott STAR S4 IR Excimer Laser System Recalled for Firing Risk
Abbott Medical Optics is recalling 1,882 STAR S4 IR Excimer Laser Systems worldwide due to an unlikely potential for inadvertent laser firing under specific conditions.
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 (laser) where injury has not yet been reported, fitting the rubric criteria for a score of 3 (High).
Plain-English summary
Abbott Medical Optics, Inc. is recalling 1,882 STAR S4 IR Excimer Laser Systems, manufactured by AMO Manufacturing USA, LLC. The recall covers Model 0030-2450 units with all serial numbers manufactured prior to July 26, 2011. These devices are Class III medical devices indicated for laser-assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
The recall is being issued because, under specific conditions, there is an unlikely potential for the laser to fire inadvertently. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The affected systems were distributed nationwide in the United States and internationally to numerous countries, including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. Healthcare providers and facilities using these devices should contact Abbott Medical Optics for instructions on how to address the potential hazard.
The recalled product
- Product
- STAR S4 IR Excimer System (STAR S4 IR) 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.
- Manufacturer
- Abbott Medical Optics, Inc.
- Hazard
- Affected units
- 1,882
Distribution
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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