Study: NCT03170154

Adverse event: Cataract operation
Serious: no
Organ System: Surgical and medical procedures
Notes: Pre-planned cataract operations in the non-study eye (non-Clareon eye) (fellow eye) are recorded as adverse events.
Frequency: 6 affected / 350 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 350 at risk

Adverse event: Macular fibrosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 350 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 350 at risk

Adverse event: Punctate keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 350 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 350 at risk

Adverse event: Herpes virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 350 at risk

Adverse event: Corneal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 350 at risk

Adverse event: Ophthalmologic treatment
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 350 at risk

Adverse event: Retinal laser coagulation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 350 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 350 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 350 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 350 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 350 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 350 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 350 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 350 at risk

Adverse event: Punctate keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 350 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 350 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 350 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 350 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 350 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 350 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 350 at risk

Adverse event: Traumatic intracranial haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 350 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 350 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 350 at risk

Adverse event: Cerebral artery embolism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 350 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 350 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 350 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Corneal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 350 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 350 at risk

Adverse event: Radical hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 350 at risk

Adverse event: Retinopexy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 350 at risk

Adverse event: Urostomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 350 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 350 at risk

Adverse event: Cataract operation
Serious: no
Organ System: Surgical and medical procedures
Notes: Pre-planned cataract operations in the non-study eye (non-Clareon eye) (fellow eye) are recorded as adverse events.
Frequency: 117 affected / 350 at risk