OptiGraft Sterile Sclera in Saline

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Description:

OptiGraft Sterile Sclera is intended for transplant where viable cells are not required. OptiGraft Sterile Sclera is recovered from deceased human donors who have granted authorization for recovery. The tissue is processed and packaged using aseptic techniques, terminally sterilized using irradiation and is provided sterile for use in ocular surgery.

Donor Selection and Screening:

Lions Eye Institute for Transplant and Research’s (LEITR’s) commitment to tissue safety begins with Donor Eligibility. All potential donors are screened for medical suitability, which includes a physical assessment, interview with a knowledgeable historian for the donor, and a review of all available medical records. All allografts from the eligible donors have been evaluated by LEITR to meet FDA regulations, the Medical Standards of the Eye Bank Association of America (EBAA) and LEITR’s internal quality control procedures.