Study: NCT03372434

Adverse event: Bothersome Visual Symptom
Serious: yes
Organ System: Product Issues
Notes: Adverse Device Effect due to report of bothersome visual symptoms causing significant impairment lasting more than 3 months postoperatively
Frequency: 1 affected / 78 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 78 at risk

Adverse event: Visual symptoms requiring secondary surgical intervention
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 78 at risk

Adverse event: Increase in cells likely due to non-compliance with ocular medication regimen
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 78 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 78 at risk

Adverse event: Bothersome visual symptom
Serious: no
Organ System: Product Issues
Notes: Adverse Device Effect due to report of bothersome visual symptoms causing significant impairment lasting more than 3 months postoperatively
Frequency: 6 affected / 78 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 73 at risk

Adverse event: Bothersome Visual Symptom
Serious: yes
Organ System: Product Issues
Notes: Adverse Device Effect due to report of bothersome visual symptoms causing significant impairment lasting more than 3 months postoperatively
Frequency: 1 affected / 73 at risk

Adverse event: Ophthalmic herpes zoster
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 73 at risk

Adverse event: Haptic anterior to capsule bag
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 73 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 73 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 73 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 73 at risk

Adverse event: Patent Foramen Ovale
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Angioplasty
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Notes: with permanent nerve damage
Frequency: 1 affected / 73 at risk

Adverse event: Undisclosed illness requiring Hospice care
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Bothersome visual symptom
Serious: no
Organ System: Product Issues
Notes: Adverse Device Effect due to report of bothersome visual symptoms causing significant impairment lasting more than 3 months postoperatively
Frequency: 1 affected / 73 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 74 at risk

Adverse event: Bothersome Visual Symptom
Serious: yes
Organ System: Product Issues
Notes: Adverse Device Effect due to report of bothersome visual symptoms causing significant impairment lasting more than 3 months postoperatively
Frequency: 1 affected / 74 at risk

Adverse event: Visual symptoms requiring secondary surgical intervention
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 74 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Bothersome visual symptom
Serious: no
Organ System: Product Issues
Notes: Adverse Device Effect due to report of bothersome visual symptoms causing significant impairment lasting more than 3 months postoperatively
Frequency: 3 affected / 74 at risk