Study: NCT00850031

Adverse event: Hospitalization secondary to prostatectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 118 at risk

Adverse event: Hospitalization due to bike accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 118 at risk

Adverse event: Stromal thinning secondary to abnormal healing response to corneal trauma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 118 at risk

Adverse event: Hip replacement surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 118 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 118 at risk

Adverse event: Flap complication
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 118 at risk

Adverse event: Vision
Serious: no
Organ System: Eye disorders
Notes: Decrease in BCDVA greater than 2 lines month 3 and later
Frequency: 9 affected / 118 at risk

Adverse event: Cornea
Serious: no
Organ System: Eye disorders
Notes: Corneal edema
Frequency: 8 affected / 118 at risk

Adverse event: Secondary Surgical Intervention
Serious: no
Organ System: Surgical and medical procedures
Notes: Inlay recentration
Frequency: 2 affected / 118 at risk

Adverse event: Secondary Surgical Intervention
Serious: no
Organ System: Surgical and medical procedures
Notes: Epithelial ingrowth removal
Frequency: 1 affected / 118 at risk

Adverse event: Intraocular pressure test
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 118 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 118 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 118 at risk

Adverse event: Limbal foreign body
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 118 at risk

Adverse event: Corneal abrasion/erosion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 118 at risk

Adverse event: Foreign bodies over inlay with anterior corneal surface defect
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 118 at risk

Adverse event: Lens
Serious: no
Organ System: Eye disorders
Notes: Cataract
Frequency: 1 affected / 118 at risk

Adverse event: Meibomian gland dysfunction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 118 at risk

Adverse event: Partial sidecut at inner edge of mask
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 118 at risk

Adverse event: Admission to hospital for severe headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Increased blood sugar
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 118 at risk

Adverse event: Scleroderma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Knee injury & surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 118 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Benign Prostate Hyperplasia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 1 affected / 118 at risk

Adverse event: Conjunctival cyst
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 1 affected / 118 at risk

Adverse event: Upper eyelid chalazion
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 1 affected / 118 at risk