Study: NCT01373580

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Not related to device
Frequency: 1 affected / 373 at risk

Adverse event: Hospitalization due to Ischemic Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Non-ocular and not related to device
Frequency: 1 affected / 373 at risk

Adverse event: Hospitalization due to Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-ocular and not related to device
Frequency: 1 affected / 373 at risk

Adverse event: Hospitalization due to adverse reaction to medication
Serious: yes
Organ System: General disorders
Notes: Infection to medication given to treat infection following surgery Seizure, reaction to systemic medication

Non-ocular and not related to device
Frequency: 2 affected / 373 at risk

Adverse event: Hospitalization for Transient Ischemic Attack
Serious: yes
Organ System: Nervous system disorders
Notes: Non-ocular and not related to device
Frequency: 1 affected / 373 at risk

Adverse event: Hospitalization for elevated blood sugar
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Non-ocular and not related to device
Frequency: 1 affected / 373 at risk

Adverse event: Hospitalization for fainting/upper extremity pain - no formal diagnosis
Serious: yes
Organ System: General disorders
Notes: Non-ocular and not related to device
Frequency: 1 affected / 373 at risk

Adverse event: Hospitalization secondary to heart disease
Serious: yes
Organ System: Cardiac disorders
Notes: Non-ocular and not related to device
Frequency: 10 affected / 373 at risk

Adverse event: Hospitalization secondary to other surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Transforminal lumbar fusion Cervical fusions with implanted plate and rods Pancreatectomy, Splenectomy (cancer) Gall Bladder removal Nephrectomy Emergency Appendectomy (2) Radical prostatectomy

Non-ocular and not related to device
Frequency: 8 affected / 373 at risk

Adverse event: Infection secondary to achilles tendon surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-ocular and not related to device
Frequency: 1 affected / 373 at risk

Adverse event: Melting of the flap
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 373 at risk

Adverse event: Surgery to repair orbital bone fracture
Serious: yes
Organ System: Eye disorders
Notes: Relationship to device unknown
Frequency: 1 affected / 373 at risk

Adverse event: Ocular infection
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 373 at risk

Adverse event: Epithelial ingrowth
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 373 at risk

Adverse event: Loss in BCDVA of > 2 lines (11 letters or more) at 3 months or later
Serious: no
Organ System: Eye disorders
Notes: BCDVA = Best Corrected Distance Visual Acuity
Frequency: 14 affected / 373 at risk

Adverse event: Late onset of haze beyond 6 months with loss of 2 lines (10 letters) or more BCVA
Serious: no
Organ System: Eye disorders
Notes: BCVA = Best Corrected Visual Acuity
Frequency: 4 affected / 373 at risk

Adverse event: Cataract (with loss in BCDVA greater than or equal to 2 lines at any time
Serious: no
Organ System: Eye disorders
Notes: BCDVA = Best Corrected Distance Visual Acuity
Frequency: 2 affected / 373 at risk

Adverse event: Increase in Intraocular Pressure of greater than 10mmHg above baseline
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 373 at risk

Adverse event: Diffuse Lamellar Keratitis (DLK)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 373 at risk

Adverse event: Secondary Surgical Intervention
Serious: no
Organ System: Eye disorders
Notes: Inlay Exchange = 18 Inlay Explant = 38 Flap Lift = 4 Cataract Surgery = 1
Frequency: 54 affected / 373 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 373 at risk

Adverse event: Transient Visual Disturbance
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 373 at risk

Adverse event: Iridocyclitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 373 at risk

Adverse event: Corneal Epithelial Defect Involving the Keratectomy
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 373 at risk

Adverse event: Broken Orbital Bone
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 373 at risk

Adverse event: Lost, Misaligned, or Misplaced Flap
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 373 at risk