Study: NCT03733730

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 453 at risk

Adverse event: Anterior capsule contraction
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 453 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 453 at risk

Adverse event: Punctate keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 453 at risk

Adverse event: Corneal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 453 at risk

Adverse event: Intra-ocular injection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 453 at risk

Adverse event: Intraocular lens repositioning
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 453 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 453 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 31 affected / 453 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 453 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 253 at risk

Adverse event: Punctate keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 253 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 253 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 253 at risk

Adverse event: Vitreoretinal traction syndrome
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 253 at risk

Adverse event: Cataract operation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 253 at risk

Adverse event: Visual field defect
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 253 at risk

Adverse event: Corneal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 253 at risk

Adverse event: Intraocular lens repositioning
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 253 at risk

Adverse event: Retinal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 253 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 253 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 253 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 253 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 453 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 453 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 453 at risk

Adverse event: Cardiac procedure complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 453 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 453 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 453 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 453 at risk

Adverse event: Spinal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 453 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1827 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1827 at risk

Adverse event: Blood urine present
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1827 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1827 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 1827 at risk

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Eye inflammation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Glare
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1827 at risk

Adverse event: Macular fibrosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Refraction disorder
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1827 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Vitreous floaters
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Vitreous prolapse
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Cataract operation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1827 at risk

Adverse event: Posterior capsule rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1827 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 1827 at risk

Adverse event: Corneal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1827 at risk

Adverse event: Injection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1827 at risk

Adverse event: Intra-ocular injection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1827 at risk

Adverse event: Intraocular lens repositioning
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 1827 at risk

Adverse event: Lens extraction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1827 at risk

Adverse event: Retinal laser coagulation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1827 at risk

Adverse event: Retinal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1827 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 1827 at risk

Adverse event: Corneal infiltrates
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1590 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1590 at risk

Adverse event: Glare
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1590 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 1590 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1590 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1590 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1590 at risk

Adverse event: Eye complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1590 at risk

Adverse event: Cataract operation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1590 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1590 at risk

Adverse event: Intra-ocular injection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1590 at risk

Adverse event: Intraocular lens repositioning
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1590 at risk

Adverse event: Lens extraction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1590 at risk

Adverse event: Retinal laser coagulation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1590 at risk

Adverse event: Retinal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1590 at risk

Adverse event: Retinopexy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1590 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1590 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1827 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1827 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1827 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1827 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1827 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1827 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1827 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1827 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1827 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1827 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1827 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1827 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1827 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Cerebral endovascular aneurysm repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1827 at risk

Adverse event: Pulmonary resection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1827 at risk

Adverse event: Mastectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1827 at risk

Adverse event: Nephrostomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1827 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1827 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1827 at risk