Common use of Serious Adverse Events Clause in Contracts

Serious Adverse Events. In addition to reporting all AEs (serious and non-serious) meeting the definitions, the Investigator must report any occurrence of the following as an SAE:  An ocular infection including a presumed infectious ulcer with any of the following characteristics: o Central or paracentral location o Penetration of Xxxxxx’x membrane o Infiltrates > 2 mm diameter o Iritis o Increase in intraocular pressure o Culture positive for microorganisms o Increasing size or severity at subsequent visits  Any central or paracentral corneal event (such as neovascularization) that results in permanent opacification  Hypopyon  Hyphema  Neovascularization within the central 6 mm of the cornea  Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit that fails to resolve  Uveitis (anterior, intermediate, or posterior)  Corneal abrasion affecting ≥ 50% of corneal surface area

Serious Adverse Events. In addition to reporting all AEs (serious and non-serious) meeting the definitions, the Investigator must report any occurrence of the following as an SAE:  • An ocular infection including a presumed infectious ulcer with any of the following characteristics: o Central or paracentral location o Penetration of Xxxxxx’x membrane o Infiltrates > 2 mm diameter o Iritis o Increase in intraocular pressure o Culture positive for microorganisms o Increasing size or severity at subsequent visits  • Any central or paracentral corneal event (such as neovascularization) that results in permanent opacification  • Hypopyon  • Hyphema  • Neovascularization within the central 6 mm of the cornea  • Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit that fails to resolve  • Uveitis (anterior, intermediate, or posterior)  • Corneal abrasion affecting ≥ 50% of corneal surface area

Serious Adverse Events. In addition to reporting all AEs (serious and non-serious) meeting the definitions, the Investigator investigator must report any occurrence of the following as an SAE:  • An ocular infection including a presumed infectious ulcer with any of the following characteristics: o Central or paracentral location o Penetration of Xxxxxx’x membrane o Infiltrates > >2 mm diameter o Iritis o Increase in intraocular pressure o Culture positive for microorganisms o Increasing size or severity at subsequent visits  • Any central or paracentral corneal event (such as neovascularization) that results in permanent opacification  • Hypopyon  • Hyphema  • Neovascularization within the central 6 mm of the cornea  • Permanent vision loss as defined by loss of 2 or more lines of BCVA (i.e., Study Lens Distance VA with Over-Refraction or Manifest Refraction BCVA) from enrollment visit that fails to resolve  • Uveitis (anterior, intermediate, or posterior)  • Corneal abrasion affecting ≥ 50≥50% of corneal surface area

Serious Adverse Events. In addition to reporting all AEs (serious and non-seriousnonserious) meeting the definitions, the Investigator investigator must report any occurrence of the following as an SAE:  • An ocular infection including a presumed infectious ulcer with any of the following characteristics: o Central or paracentral location o Penetration of Xxxxxx’x membrane o Infiltrates > 2 mm diameter o Iritis o Increase in intraocular pressure o Culture positive for microorganisms o Increasing size or severity at subsequent visits  • Any central or paracentral corneal event (such as neovascularization) that results in permanent opacification  • Hypopyon  • Hyphema  • Neovascularization within the central 6 mm of the cornea  • Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit that fails to resolve  • Uveitis (anterior, intermediate, or posterior)  • Corneal abrasion affecting ≥ 50% of corneal surface area