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# CorneaGen Recalls 1 Lot of Scleral Patch Grafts
- URL: https://www.fdaweb.com/corneagen-recalls-1-lot-of-scleral-patch-grafts/
- Published: 2022-05-23T12:00:00.000Z
- Updated: 2026-09-14T17:45:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151875

FDA says CorneaGen recalled 1/11 one lot of scleral patch grafts that were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and HIV NAT and were shipped before being medically cleared. An agency [notice](https://www.fda.gov/vaccines-blood-biologics/recalls-biologics/urgent-voluntary-recall-corneagen-sclera-scleral-patch-grafts-corneagen-voluntarily-recalling-entire?ref=fdaweb.com) says the 1/11 recall instructed customers to review product lot information for any scleral patch grafts they received and schedule return and replacement if necessary.

A company 3/18 notification gave customers the reason for the recall and provided an FDA recommendation that implanting doctors share the information with the graft recipients and that recipients should be counseled and tested for HIV-1 and anti-HIV-2 and HIV NAT.