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.
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 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.
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