CorneaGen recalls corneal, scleral patch grafts
Click Here to Manage Email Alerts
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 and W419221004861103, as well as scleral patch grafts obtained from lot number W419221008338.
CorneaGen notified customers of the product recalls in January. In March, the company informed customers that the FDA recommends that implanting physicians share the notification with graft recipients and that recipients should be counseled and tested for anti-HIV-1, anti-HIV-2 and HIV NAT.
Physicians with questions or concerns should contact christina.cooper@corneagen.com or 206-278-8274.
Reference:
- Urgent voluntary recall: CorneaGen sclera / scleral patch grafts; CorneaGen is voluntarily recalling the entire lot of scleral patch grafts obtained from (lot number) W419221008338. https://www.fda.gov/vaccines-blood-biologics/recalls-biologics/urgent-voluntary-recall-corneagen-sclera-scleral-patch-grafts-corneagen-voluntarily-recalling-entire. Accessed May 26, 2022.
Read more about
Click Here to Manage Email Alerts