Abbott STAR S4 Excimer Laser System Recalled for Potential Inadvertent Firing
Abbott Medical Optics is recalling STAR S4 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (laser firing) where injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical hazards without confirmed harm.
Plain-English summary
Abbott Medical Optics, Inc. is recalling the STAR S4 with Variable Spot Scanning Excimer System. This Class III medical device is indicated for laser-assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The recall affects 1,882 systems manufactured prior to July 26, 2011, with model number 0030-4077.
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 worldwide, including in the United States and numerous international markets. Consumers and healthcare providers should contact Abbott Medical Optics for instructions on how to address this issue.
The recalled product
- Product
- STAR S4 with Variable Spot Scanning Excimer System (STAR S4) 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…
- 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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