Agency classClass IIOur severity:High FDA (Devices)·Z-1541-2013·Announced 2013-06-19

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.

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 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.
Category: Medical Device — Ophthalmic Laser
Hazard: unintended-laser-firing
Affected units: 1,882

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · Abbott Medical Optics, Inc.

See all →

High
Abbott OptiMedica Catalys Precision Laser System Recalled for Corneal Scoring Risk
FDA (Devices) · 2015-04-29
High
Abbott Medical Optics Recalls STAR Excimer Laser Systems Due to Component Failure
FDA (Devices) · 2013-10-30
High
Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure
FDA (Devices) · 2013-10-30
High
Abbott Recalls STAR Excimer Laser Systems Due to Power Component Failure
FDA (Devices) · 2013-10-30
Moderate
Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure
FDA (Devices) · 2013-10-30

Same hazard · unintended laser firing