MONOFOCAL IOLS
This device is manufactured by ABBOTT MEDICAL OPTICS, JOHNSON & JOHNSON SURGICAL VISION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Material Opacification | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Material Fragmentation | 1 | Device |
| 2022 | Inaccurate Delivery | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 1 | Device |
| 2022 | Break | 5 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Material Twisted/Bent | 3 | Device |
| 2020 | Material Opacification | 3 | Device |
| 2020 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2020 | Failure to Unfold or Unwrap | 1 | Device |
| 2020 | Device Dislodged or Dislocated | 1 | Device |
| 2020 | Device Damaged Prior to Use | 1 | Device |
| 2020 | Contamination | 1 | Device |
| 2020 | Calcified | 1 | Device |
| 2020 | Break | 9 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2019 | Separation Problem | 1 | Device |
| 2019 | Scratched Material | 1 | Device |
| 2019 | Positioning Problem | 3 | Device |
| 2019 | Material Twisted/Bent | 2 | Device |
| 2019 | Material Split, Cut or Torn | 1 | Device |
| 2019 | Failure to Fold | 1 | Device |
| 2019 | Device Damaged Prior to Use | 1 | Device |
| 2019 | Crack | 1 | Device |
| 2019 | Contamination /Decontamination Problem | 1 | Device |
| 2019 | Contamination | 1 | Device |
| 2019 | Calcified | 1 | Device |
| 2019 | Break | 5 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Torn Material | 4 | Device |
| 2018 | Separation Problem | 8 | Device |
| 2018 | Scratched Material | 4 | Device |
| 2018 | Positioning Problem | 2 | Device |
| 2018 | Positioning Failure | 1 | Device |
| 2018 | Pitted | 1 | Device |
| 2018 | Optical Discoloration | 2 | Device |
| 2018 | Material Twisted/Bent | 5 | Device |
| 2018 | Material Split, Cut or Torn | 4 | Device |
| 2018 | Material Deformation | 1 | Device |
| 2018 | Inadequacy of Device Shape and/or Size | 11 | Device |
| 2018 | Failure to Unfold or Unwrap | 1 | Device |
| 2018 | Failure to Eject | 1 | Device |
| 2018 | Failure to Align | 1 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 3 | Device |
| 2018 | Detachment Of Device Component | 2 | Device |
| 2018 | Crack | 2 | Device |
| 2018 | Contamination /Decontamination Problem | 4 | Device |
| 2018 | Break | 25 | Device |
| 2018 | Bent | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 27 | Device |
| 2017 | Torn Material | 9 | Device |
| 2017 | Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 1 | Device |
| 2017 | Scratched Material | 11 | Device |
| 2017 | Positioning Problem | 1 | Device |
| 2017 | Material Opacification | 1 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Inadequacy of Device Shape and/or Size | 6 | Device |
| 2017 | Hole In Material | 1 | Device |
| 2017 | Failure to Unfold or Unwrap | 2 | Device |
| 2017 | Difficult or Delayed Positioning | 2 | Device |
| 2017 | Difficult To Position | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Device Damaged Prior to Use | 1 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 11 | Device |
| 2017 | Crack | 5 | Device |
| 2017 | Break | 5 | Device |
| 2017 | Bent | 4 | Device |
| 2017 | Appropriate Term/Code Not Available | 7 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 27 | Device |
| 2016 | Use of Device Problem | 1 | Device |
| 2016 | Unintended Movement | 1 | Device |
| 2016 | Torn Material | 6 | Device |
| 2016 | Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 4 | Device |
| 2016 | Scratched Material | 3 | Device |
| 2016 | Positioning Problem | 1 | Device |
| 2016 | Material Opacification | 3 | Device |
| 2016 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2016 | Failure to Unfold or Unwrap | 1 | Device |
| 2016 | Difficult To Position | 1 | Device |
| 2016 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2016 | Detachment Of Device Component | 1 | Device |
| 2016 | Break | 1 | Device |
| 2016 | Appropriate Term/Code Not Available | 4 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 26 | Device |
| 2015 | Torn Material | 1 | Device |
| 2015 | Invalid Sensing | 1 | Device |
| 2015 | Incorrect Measurement | 2 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2014 | Torn Material | 5 | Device |
| 2014 | Sticking | 1 | Device |
| 2014 | Patient-Device Incompatibility | 1 | Device |
| 2014 | Material Separation | 1 | Device |
| 2014 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2014 | Device Operates Differently Than Expected | 3 | Device |
| 2014 | Device Markings/Labelling Problem | 16 | Device |
| 2014 | Device Handling Problem | 1 | Device |
| 2014 | Break | 3 | Device |
| 2014 | Bent | 2 | Device |
| 2014 | Appropriate Term/Code Not Available | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 31 | Device |
| 2013 | Material Opacification | 1 | Device |
| 2013 | Fracture | 1 | Device |
| 2013 | Device Markings/Labelling Problem | 3 | Device |
| 2013 | Appropriate Term/Code Not Available | 3 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 4 | Device |