Study: NCT00407602

Adverse event: Conjunctival dehiscence
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 30 at risk

Adverse event: Conjunctival erosion
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 30 at risk

Adverse event: Ulcerative keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Endophthalmitis - infective
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 30 at risk

Adverse event: Epiretinal membrane
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypotony
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 30 at risk

Adverse event: Iris rubeosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Keratitis - infective
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Migration (extra-ocular) of intraocular silicone oil
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Re-tack
Serious: yes
Organ System: Eye disorders
Notes: Re-tack to hold the device in place on the retina
Frequency: 2 affected / 30 at risk

Adverse event: Retinal detachment - rhegmatogenous
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 30 at risk

Adverse event: Retinal detachment - tractional and serous
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: 360 Circumferential Vitreous Band Traction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Choroidal detachment
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 30 at risk

Adverse event: Choroidal effusion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 30 at risk

Adverse event: Conjunctival cyst
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Conjunctival dehiscence
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Conjunctival erosion
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Conjunctivitis - inflammatory
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 30 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Corneal dryness
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Corneal epithelial defect
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Corneal fold
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Corneal opacity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Corneal Suture Broken
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Corneal vascularization
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Decrease in light perception
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Elective revision surgery
Serious: no
Organ System: Eye disorders
Notes: Better placement of array on retina
Frequency: 7 affected / 30 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 30 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 30 at risk

Adverse event: Fibrosis around retinal tack
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Foreign Body Sensation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Eye disorders
Notes: Adjudicated as device related
Frequency: 3 affected / 30 at risk

Adverse event: High IOP
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hyphaema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hypotony
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 30 at risk

Adverse event: Inflammation - ocular
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 30 at risk

Adverse event: Irregular pupil
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Keratic precipitates
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Adjudicated as device or procedure related
Frequency: 1 affected / 30 at risk

Adverse event: Nystagmus increase
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ocular fibrin
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - ocular
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 30 at risk

Adverse event: Pre-retinal hemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Proliferative vitreoretinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Retinal Break/Tear
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Retinal detachment - tractional
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Retinal folds
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Retinal Thickening - cystoid macular edema (CME)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 30 at risk

Adverse event: Retinal Thickening - without cystic changes
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 30 at risk

Adverse event: Retinoschisis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Revision Surgery - tack replacement
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rubeosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Scleral graft displacement or reabsorption
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Scleritis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Suture irritation
Serious: no
Organ System: General disorders
Notes: Associated with surgical procedure
Frequency: 6 affected / 30 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 30 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 30 at risk