Study: NCT03811249

Adverse event: Ischemic Stroke w/ 2ndary Cortical Left Inferior Homonymous Hemianopsia
Serious: yes
Organ System: Nervous system disorders
Notes: Non-Ocular Non-Device Related Serious Adverse Event
Frequency: 1 affected / 287 at risk

Adverse event: COVID-19 Infection
Serious: yes
Organ System: Infections and infestations
Notes: Non-Ocular, Non-Device Related Serious Adverse Event
Frequency: 1 affected / 287 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Non-Ocular Non-Device Related Serious Adverse Event
Frequency: 1 affected / 287 at risk

Adverse event: Sepsis of the Left Lower Leg leading to BKA and Coma
Serious: yes
Organ System: Infections and infestations
Notes: Non-Ocular Non-Device related Serious Adverse Event
Frequency: 1 affected / 287 at risk

Adverse event: Decrease in BCDVA of greater than or equal to 2 lines
Serious: no
Organ System: Eye disorders
Notes: Decrease in BCDVA of greater than or equal to 2 lines
Frequency: 4 affected / 287 at risk

Adverse event: Chalazion/Lid Margin Disease
Serious: no
Organ System: Eye disorders
Notes: Chalazion, or onset of or worsening to severe, clinically signficant lid margin disease
Frequency: 3 affected / 287 at risk

Adverse event: Dry Eye signs requiring prescription
Serious: no
Organ System: Eye disorders
Notes: Dry Eye signs requiring prescription medication
Frequency: 2 affected / 287 at risk

Adverse event: Conjunctival cyst
Serious: no
Organ System: Eye disorders
Notes: Conjunctival Cyst
Frequency: 3 affected / 287 at risk

Adverse event: Conjunctival erosion
Serious: no
Organ System: Eye disorders
Notes: Conjunctival Erosion
Frequency: 1 affected / 287 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Subconjunctival hemorrhage not associated wtih an explant, concomitant procedure, etc.
Frequency: 5 affected / 287 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Conjunctivitis (allergic, bacterial, or viral)
Frequency: 3 affected / 287 at risk

Adverse event: Lenticular opacities
Serious: no
Organ System: Eye disorders
Notes: Lens Opacity--2 grade change as compared to preoperative baseline
Frequency: 7 affected / 287 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Posterior Vitreous Detachment
Frequency: 2 affected / 287 at risk

Adverse event: Secondary Surgical Intervention-Complete Explant
Serious: no
Organ System: Eye disorders
Notes: Explant of all 4 segments or all remaining segments from eye
Frequency: 2 affected / 287 at risk

Adverse event: Secondary Surgical Intervention-Partial Explant
Serious: no
Organ System: Eye disorders
Notes: Individual or multiple segments removed with at least 1 remaining segment
Frequency: 2 affected / 287 at risk

Adverse event: Secondary Surgical Intervention-Cataract Extraction
Serious: no
Organ System: Eye disorders
Notes: Cataract Extractiion
Frequency: 2 affected / 287 at risk

Adverse event: Other Surgical Intervention
Serious: no
Organ System: Eye disorders
Notes: Other Surgical interventon--clear lens extraction, photorefractive keratectomy
Frequency: 3 affected / 287 at risk

Adverse event: Central serous chorioretinopathy
Serious: no
Organ System: Eye disorders
Notes: Central Serous Chorioretinopathy
Frequency: 2 affected / 287 at risk

Adverse event: Chemical burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: non-devic, non-procedure related ocular chemical injury
Frequency: 1 affected / 287 at risk

Adverse event: cotton wool spot
Serious: no
Organ System: Eye disorders
Notes: retinal finding associated with systemic hypertension
Frequency: 1 affected / 287 at risk

Adverse event: Dry Eye Symptoms requiring prescription medication
Serious: no
Organ System: Eye disorders
Notes: Patient reports of dry eye symptoms despite no clinical signs of dry eye--prescription medication was prescribed
Frequency: 4 affected / 287 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Notes: Epiretinal membrane
Frequency: 2 affected / 287 at risk

Adverse event: Foreign Body Sensation
Serious: no
Organ System: Eye disorders
Notes: Ocular Foreign Body Sensation
Frequency: 1 affected / 287 at risk

Adverse event: Lattice Degeneration
Serious: no
Organ System: Eye disorders
Notes: Lattice Degeneration
Frequency: 2 affected / 287 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Endocrine disorders
Notes: Non-device related finding associated with systemic diabetes
Frequency: 1 affected / 287 at risk

Adverse event: Ophthalmic migraine
Serious: no
Organ System: Vascular disorders
Notes: Ocular Migraine
Frequency: 1 affected / 287 at risk

Adverse event: Pyogenic granuloma
Serious: no
Organ System: Eye disorders
Notes: Pyogenic Granuloma
Frequency: 1 affected / 287 at risk

Adverse event: Recurrent Corneal Erosion
Serious: no
Organ System: Eye disorders
Notes: Injury related recurrent corneal erosion, not device or procedure related
Frequency: 1 affected / 287 at risk

Adverse event: Trichiasis of single lash right lower lid
Serious: no
Organ System: Eye disorders
Notes: Not device/procedure related
Frequency: 1 affected / 287 at risk