Abbott OptiMedica Catalys Precision Laser System Recalled for Corneal Scoring Risk
Abbott Medical Optics is recalling 202 OptiMedica Catalys Precision Laser Systems because loss of suction during cataract surgery may cause corneal scoring.
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 (corneal scoring) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Abbott Medical Optics, Inc. is recalling 202 units of the OptiMedica Catalys Precision Laser System, including models Catalys-U and Catalys-I. The devices are indicated for use in patients undergoing cataract surgery for the removal of the crystalline lens.
The recall is due to a potential loss of suction during treatment, which may result in scoring the cornea during lens fragmentation. The affected devices were distributed worldwide, including the United States, Canada, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Thailand, Colombia, Ecuador, Italy, Brazil, Egypt, Tunisia, Belgium, Mexico, Greece, Guatemala, Chile, Turkey, Peru, Hong Kong, Saudi Arabia, Bangladesh, and the Dominican Republic.
Healthcare providers should identify affected devices by checking the serial numbers listed in the recall notice. Patients who have undergone cataract surgery with these devices should contact their healthcare provider for further evaluation.
The recalled product
- Product
- OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
- Manufacturer
- Abbott Medical Optics, Inc.
- Affected units
- 202
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Abbott Medical Optics, Inc.
See all →- HighAbbott Recalls STAR Excimer Laser Systems Due to Power Component Failure
FDA (Devices) · 2013-10-30
- HighAbbott Medical Optics Recalls STAR Excimer Laser Systems Due to Component Failure
FDA (Devices) · 2013-10-30
- HighAbbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure
FDA (Devices) · 2013-10-30
- ModerateAbbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure
FDA (Devices) · 2013-10-30
- HighAbbott Sovereign Compact Phacoemulsification System Recalled for Vacuum Loss Risk
FDA (Devices) · 2013-07-17
Similar recalls
- HighOptiMedica Catalys Precision Laser System Software Recall for Incorrect Parameters
FDA (Devices) · 2015-06-03
- HighOptiMedica Catalys Precision Laser System Recalled for Software Alignment Failures
FDA (Devices) · 2018-10-10
- HighOptimedica Catalys Precision Laser System Recalled for Transformer Heating Risk
FDA (Devices) · 2014-01-15
- ModerateAbbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure
FDA (Devices) · 2016-09-28
- HighAlcon Recalls LenSx Lasers Due to Incomplete Corneal Flap Creation
FDA (Devices) · 2016-05-25
- ModerateAbbott Recalls TECNIS Intraocular Lenses Due to Mislabeled Units
FDA (Devices) · 2016-09-28