Study: NCT01352442

Adverse event: Complete division of left Achilles tendon
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: All Serious Adverse Events reported in this study were not related to the eye.
Frequency: 1 affected / 151 at risk

Adverse event: Brain and Lung cancer requiring extended hospitalization
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: All Serious Adverse Events reported in this study were not related to the eye.
Frequency: 1 affected / 151 at risk

Adverse event: Hospitalization for investigation of bladder. Suspected cancer. Planned event.
Serious: yes
Organ System: Investigations
Notes: All Serious Adverse Events reported in this study were not related to the eye.
Frequency: 1 affected / 151 at risk

Adverse event: Hospitalization for laser treatment of bladder cancer. Planned event
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: All Serious Adverse Events reported in this study were not related to the eye.
Frequency: 1 affected / 151 at risk

Adverse event: Hospitalisation for Systemic Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: All Serious Adverse Events reported in this study were not related to the eye.
Frequency: 1 affected / 151 at risk

Adverse event: Hospitalization for Atrial Fibrilation
Serious: yes
Organ System: Cardiac disorders
Notes: All Serious Adverse Events reported in this study were not related to the eye.
Frequency: 1 affected / 151 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: All Serious Adverse Events reported in this study were not related to the eye.
Frequency: 1 affected / 151 at risk

Adverse event: Corneal Edema with grade of greater than or equal to 2+ (at one month or later)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 151 at risk

Adverse event: Epithelial Ingrowth
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 151 at risk

Adverse event: Intraocular pressure test
Serious: no
Organ System: Eye disorders
Notes: Intraocular pressure increase greater than 10 mmHg above baseline or Intraocular pressure greater than 25 mmHg (with clinical findings)
Frequency: 7 affected / 151 at risk

Adverse event: Allergic reaction to study medication (lids)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 151 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 151 at risk

Adverse event: AcuFocus Corneal Inlay re-centration or replacement
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 151 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 151 at risk

Adverse event: Decrease in Best Corrected Distance Visual Acuity greater than 2 lines at Month 3 or later
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 151 at risk

Adverse event: Bone fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 151 at risk

Adverse event: Adenoviral conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 151 at risk

Adverse event: Atrial Fibrilation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Flap complication
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 151 at risk