Study: NCT01424189

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 386 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 386 at risk

Adverse event: Cystoid macular oedema (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Cystoid macular oedema (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 383 at risk

Adverse event: Eye disorder (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Eye disorder (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 383 at risk

Adverse event: Glare (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Glare (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 383 at risk

Adverse event: Halo vision (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Halo vision (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 383 at risk

Adverse event: Iris atrophy (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Iris atrophy (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 383 at risk

Adverse event: Macular hole (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 383 at risk

Adverse event: Photopsia (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Photopsia (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 383 at risk

Adverse event: Retinal detachment (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Retinal detachment (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 383 at risk

Adverse event: Retinal tear (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 383 at risk

Adverse event: Vision blurred (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Visual impairment (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Visual impairment (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 383 at risk

Adverse event: Vitreous prolapse (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 386 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 386 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 386 at risk

Adverse event: Device dislocation (First Implanted Eye)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 386 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 386 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 386 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 386 at risk

Adverse event: Cataract operation complication (First Implanted Eye)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 386 at risk

Adverse event: Cataract operation complication (Second Implanted Eye)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Eye injury (Second Implanted Eye)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 386 at risk

Adverse event: Surgical procedure repeated (First Implanted Eye)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 386 at risk

Adverse event: Surgical procedure repeated (Second Implanted Eye)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Wound complication (Second Implanted Eye)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 386 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 386 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 386 at risk

Adverse event: Breast cancer stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 386 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 386 at risk

Adverse event: Gastric neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 386 at risk

Adverse event: Neuroendocrine carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 386 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 386 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 386 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 386 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Corneal operation (First Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 386 at risk

Adverse event: Corneal operation (Second Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 383 at risk

Adverse event: Eye laser surgery (First Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 386 at risk

Adverse event: Eye laser surgery (Second Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 383 at risk

Adverse event: Intraocular lens repositioning (First Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 386 at risk

Adverse event: Keratometry (First Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 386 at risk

Adverse event: Keratomileusis (First Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 386 at risk

Adverse event: Keratomileusis (Second Implanted Eye) A
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 383 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 386 at risk

Adverse event: Retinal operation (Second Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 383 at risk

Adverse event: Retinopexy (First Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 386 at risk

Adverse event: Retinopexy (Second Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 383 at risk

Adverse event: Rotator cuff repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 386 at risk

Adverse event: Suture insertion (Second Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 383 at risk

Adverse event: Vitrectomy (First Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 386 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 386 at risk

Adverse event: Dry Eye (Second Implanted Eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 383 at risk

Adverse event: Posterior capsule opacification (First Implanted Eye)
Serious: no
Organ System: Eye disorders
Frequency: 35 affected / 386 at risk

Adverse event: Posterior capsule opacification (Second Implanted Eye)
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 383 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 188 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 188 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 188 at risk

Adverse event: Age-related macular degeneration (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 188 at risk

Adverse event: Cystoid macular oedema (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 188 at risk

Adverse event: Halo vision (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 188 at risk

Adverse event: Halo vision (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 188 at risk

Adverse event: Macular oedema (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 188 at risk

Adverse event: Retinal detachment (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 188 at risk

Adverse event: Vision blurred (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 188 at risk

Adverse event: Visual impairment (First Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 188 at risk

Adverse event: Visual impairment (Second Implanted Eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 188 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 188 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 188 at risk

Adverse event: Cataract operation complication (Second Implanted Eye)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 188 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 188 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 188 at risk

Adverse event: Surgical procedure repeated (First Implanted Eye)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 188 at risk

Adverse event: Surgical procedure repeated (Second Implanted Eye)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 188 at risk

Adverse event: Wound complication (Second Implanted Eye)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 188 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 188 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 188 at risk

Adverse event: Non-cardiogenic pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 188 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 188 at risk

Adverse event: Corneal operation (First Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 188 at risk

Adverse event: Corneal operation (Second Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 188 at risk

Adverse event: Intraocular injection (First Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 188 at risk

Adverse event: Retinopexy (Second Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 188 at risk

Adverse event: Suture insertion (Second Implanted Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 188 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 188 at risk

Adverse event: Dry Eye (Second Implanted Eye)
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 188 at risk

Adverse event: Posterior capsule opacification (First Implanted Eye)
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 188 at risk

Adverse event: Posterior capsule opacification (Second Implanted Eye)
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 188 at risk