Study: NCT03111550

Adverse event: Secondary Surgical Intervention: IOL removal
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 78 at risk

Adverse event: Hernia Surgical repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 78 at risk

Adverse event: Diverticulitis of Large intestine with perforation resulting in hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Death during sleep
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Hospitalization due to surgical removal of tumors
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 78 at risk

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

Adverse event: Hospitalization due to hip fracture secondary to fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: ADE, Bothersome visual symptoms causing significant impairment lasting more than 3 mos postop
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 78 at risk

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

Adverse event: Secondary Surgical Intervention: IOL removal
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 73 at risk

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

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

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

Adverse event: Lens removal due to undesired optical phenomena due to fixed pupil
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hospitalization due to cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 73 at risk

Adverse event: ADE, Bothersome visual symptoms causing significant impairment lasting more than 3 mos postop
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 73 at risk

Adverse event: Blood Clot in leg requiring emergency angioplasty
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 79 at risk

Adverse event: Secondary Surgical Intervention: IOL removal
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 79 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 79 at risk

Adverse event: Death secondary to cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 79 at risk

Adverse event: Hospitalization due to weakness secondary to cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 79 at risk

Adverse event: ADE, Bothersome visual symptoms causing significant impairment lasting more than 3 mos postop
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 79 at risk