CATALYS SYSTEM
Received Jan 27, 2026
Report 3012236936-2026-000022 · MDR key 24196483
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Johnson & Johnson Surgical Vision, Inc.Model number
CATALYS-UCatalog number
CATALYS-U
Product problems
- Decrease in Suction
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE EVALUATION: SEVEN (7) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICES THAT INCLUDED LABELING, MANUALS, AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEMS AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
Description of Event or Problem
THIS REPORT SUMMARIZES 17 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Additional Manufacturer Narrative
H10 -LIST OF ALL SERIAL NUMBERS OF THE DEVICES AND QUANTITY (B)(6). FIVE (5) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.