Abbott STAR S3 Excimer Laser System Recalled for Firing Risk
Abbott Medical Optics is recalling STAR S3 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 high-risk medical device where a hazard (inadvertent laser firing) exists, but the source text describes the potential as 'unlikely' and 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 S3 ActiveTrack Excimer System (STAR S3), a Class III medical device indicated for laser-assisted in situ keratomileusis (LASIK) eye surgery. The recall covers 1,882 systems manufactured prior to July 26, 2011, with model number 0030-4864.
The recall is being issued because, under specific conditions, there is an unlikely potential for the laser to fire inadvertently. The affected devices were distributed worldwide, including in the United States and numerous international markets.
Healthcare providers and consumers should contact Abbott Medical Optics for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- STAR S3 ActiveTrack Excimer System (STAR S3) 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…
- 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
Same manufacturer · Abbott Medical Optics, Inc.
See all →- HighAbbott OptiMedica Catalys Precision Laser System Recalled for Corneal Scoring Risk
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