Chapter 2 System Overview
Page 32 of 314 Part Number: 0160-6411, Rev A, 02/2019
Software Release: cOS 5.00
Table 2.2 Cumulative Dissipated Energy (CDE) Values
Safety of the CATALYS® System was evaluated by tallying all subject complications and adverse
events and comparing these findings to those of the surgical Control cohort. Non-device-related
complications and adverse events were found to be comparable between the two cohorts.
Device-related complications ascribed to the CATALYS® System were limited to petechiae (72%
of eyes) and subconjunctival hemorrhage (5% of eyes). All device-related complications were
determined to be mild and transitory in nature, as all resolved in less than 30 days without the
need for additional medical intervention.
Cumulative Dissipated Energy (CDE) CATALYS® System Control
Mean 10.39 18.54
Standard Deviation 6.61 12.07
Minimum 0.91 5.23
Maximum 27.65 47.86
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