CONSTELLATION
This device is manufactured by ALCON RESEARCH - IRVINE TECHNOLOGY CENTER.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Retinal Tear | 1 | Patient |
| 2024 | Retinal Detachment | 1 | Patient |
| 2024 | Intraocular Pressure Increased | 1 | Patient |
| 2024 | Intraocular Pressure Decreased | 2 | Patient |
| 2024 | Insufficient Information | 124 | Patient |
| 2024 | Eye Burn | 1 | Patient |
| 2024 | Endophthalmitis | 1 | Patient |
| 2024 | Corneal Edema | 1 | Patient |
| 2024 | Burn(s) | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 5 | Patient |
| 2024 | Unexpected Shutdown | 6 | Device |
| 2024 | Suction Problem | 9 | Device |
| 2024 | Suction Failure | 17 | Device |
| 2024 | Reflux within Device | 1 | Device |
| 2024 | Program or Algorithm Execution Problem | 1 | Device |
| 2024 | Priming Problem | 1 | Device |
| 2024 | Pressure Problem | 8 | Device |
| 2024 | Premature End-of-Life Indicator | 1 | Device |
| 2024 | Output Problem | 3 | Device |
| 2024 | Operating System Becomes Nonfunctional | 6 | Device |
| 2024 | Noise, Audible | 3 | Device |
| 2024 | No Flow | 1 | Device |
| 2024 | No Device Output | 2 | Device |
| 2024 | Infusion or Flow Problem | 6 | Device |
| 2024 | Inability to Irrigate | 4 | Device |
| 2024 | Improper Flow or Infusion | 12 | Device |
| 2024 | Gas/Air Leak | 2 | Device |
| 2024 | Firing Problem | 1 | Device |
| 2024 | Failure to Power Up | 2 | Device |
| 2024 | Failure to Fire | 4 | Device |
| 2024 | Failure to Deliver Energy | 7 | Device |
| 2024 | Failure to Cut | 42 | Device |
| 2024 | Energy Output Problem | 17 | Device |
| 2024 | Decrease in Suction | 5 | Device |
| 2024 | Decrease in Pressure | 1 | Device |
| 2024 | Continuous Firing | 1 | Device |
| 2024 | Complete Loss of Power | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 13 | Device |
| 2024 | Application Program Problem: Parameter Calculation Error | 1 | Device |
| 2024 | Application Program Freezes, Becomes Nonfunctional | 3 | Device |
| 2024 | Ambient Noise Problem | 1 | Device |
| 2024 | Air/Gas in Device | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Retinal Detachment | 1 | Patient |
| 2023 | Intraocular Pressure Decreased | 3 | Patient |
| 2023 | Insufficient Information | 3 | Patient |
| 2023 | Eye Burn | 2 | Patient |
| 2023 | Capsular Bag Tear | 1 | Patient |
| 2023 | Blister | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 5 | Patient |
| 2023 | Unexpected Shutdown | 9 | Device |
| 2023 | Suction Problem | 8 | Device |
| 2023 | Suction Failure | 3 | Device |
| 2023 | Self-Activation or Keying | 1 | Device |
| 2023 | Pressure Problem | 8 | Device |
| 2023 | Power Problem | 2 | Device |
| 2023 | Operating System Becomes Nonfunctional | 12 | Device |
| 2023 | Noise, Audible | 4 | Device |
| 2023 | No Pressure | 1 | Device |
| 2023 | No Flow | 5 | Device |
| 2023 | Misfire | 1 | Device |
| 2023 | Intermittent Energy Output | 4 | Device |
| 2023 | Infusion or Flow Problem | 3 | Device |
| 2023 | Increase in Suction | 1 | Device |
| 2023 | Inability to Irrigate | 2 | Device |
| 2023 | Gas Output Problem | 7 | Device |
| 2023 | Failure to Prime | 2 | Device |
| 2023 | Failure to Infuse | 1 | Device |
| 2023 | Failure to Deliver Energy | 7 | Device |
| 2023 | Failure to Cut | 14 | Device |
| 2023 | Failure to Calibrate | 1 | Device |
| 2023 | Energy Output Problem | 15 | Device |
| 2023 | Defective Component | 1 | Device |
| 2023 | Decrease in Suction | 14 | Device |
| 2023 | Decrease in Pressure | 1 | Device |
| 2023 | Continuous Firing | 1 | Device |
| 2023 | Connection Problem | 1 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 19 | Device |
| 2023 | Application Program Freezes, Becomes Nonfunctional | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Unexpected Shutdown | 7 | Device |
| 2022 | Suction Problem | 5 | Device |
| 2022 | Suction Failure | 1 | Device |
| 2022 | Pressure Problem | 7 | Device |
| 2022 | Output above Specifications | 1 | Device |
| 2022 | Operating System Becomes Nonfunctional | 16 | Device |
| 2022 | Noise, Audible | 5 | Device |
| 2022 | No Flow | 1 | Device |
| 2022 | Misfire | 1 | Device |
| 2022 | Key or Button Unresponsive/not Working | 1 | Device |
| 2022 | Infusion or Flow Problem | 1 | Device |
| 2022 | Gas/Air Leak | 1 | Device |
| 2022 | Gas Output Problem | 2 | Device |
| 2022 | Fluid/Blood Leak | 1 | Device |
| 2022 | Failure to Prime | 2 | Device |
| 2022 | Failure to Infuse | 1 | Device |
| 2022 | Failure to Fire | 2 | Device |
| 2022 | Failure to Deliver Energy | 12 | Device |
| 2022 | Failure to Cut | 10 | Device |
| 2022 | Energy Output Problem | 22 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Decrease in Suction | 7 | Device |
| 2022 | Component or Accessory Incompatibility | 1 | Device |
| 2022 | Backflow | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 22 | Device |
| 2022 | Application Program Freezes, Becomes Nonfunctional | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2021 | No Audible Alarm | 1 | Device |
| 2021 | Failure to Cut | 1 | Device |
| 2020 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2020 | Operating System Becomes Nonfunctional | 1 | Device |
| 2020 | Noise, Audible | 1 | Device |
| 2020 | Leak/Splash | 2 | Device |