OPHTHALMIC FEMTOSECOND LASER
This device is manufactured by ALCON - LENSX LASERS, ALCON LENSX, ALCON RESEARCH - IRVINE TECHNOLOGY CENTER, MEDTRONIC PERFUSION SYSTEMS, PERFUSION SYSTEMS and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 16 | Patient |
| 2024 | Corneal Perforation | 1 | Patient |
| 2024 | Capsular Bag Tear | 4 | Patient |
| 2024 | Appropriate Term / Code Not Available | 2 | Patient |
| 2024 | Suction Problem | 2 | Device |
| 2024 | Radiofrequency Interference (RFI) | 1 | Device |
| 2024 | Failure to Cut | 1 | Device |
| 2024 | Failure to Align | 14 | Device |
| 2024 | Energy Output Problem | 1 | Device |
| 2024 | Device Difficult to Maintain | 1 | Device |
| 2024 | Decrease in Suction | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2024 | Application Program Freezes, Becomes Nonfunctional | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2024 | Accessory Incompatible | 1 | Device |
| 2023 | Insufficient Information | 8 | Patient |
| 2023 | Capsular Bag Tear | 6 | Patient |
| 2023 | Appropriate Term / Code Not Available | 5 | Patient |
| 2023 | Suction Problem | 1 | Device |
| 2023 | Failure to Align | 9 | Device |
| 2023 | Device Difficult to Maintain | 1 | Device |
| 2023 | Contamination | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 3 | Device |
| 2023 | Application Program Freezes, Becomes Nonfunctional | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2022 | Unintended Movement | 2 | Device |
| 2022 | Failure to Align | 9 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2020 | Retinal Detachment | 1 | Patient |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |