CorneaGen issued product recalls for certain corneal and scleral patch grafts, according to press releases from the FDA.
The corneal grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody; additional results found the donor to be nonreactive for HIV I/II NAT testing. The scleral grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and HIV NAT. The grafts were shipped before being medically cleared.
CorneaGen is voluntarily recalling corneal patch grafts with the product numbers W419221004861104, W419221004861105, W419221004861106