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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Corneal Patch Grafts by CorneaGen: Recall - Due to donor of the cornea tested reactive for HIV-1/HIV-2 Plus O antibody
AUDIENCE: Patient, Health Professional, Risk Manager, Eye Care, Surgery
ISSUE: CorneaGen is recalling Corneal Patch Grafts bearing the following product numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103 because the Cornea Patch Grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and were shipped prior to being medically cleared. Additional serology results found the donor to be non-reactive for HIV I/II NAT testing.
For more information about this recall, click on the red button "Read Recall" below.
RECOMMENDATIONS:
- CorneaGen issued a Product Recall Letter dated January 14, 2022. Customers who received the Cornea Patch Grafts are instructed to review the product lot information and if any affected product remains within their facility to contact the company.
- ConreaGen issued a second notification letter dated March 18, 2022. This notification informed customers of the reason for the letter dated January 14, 2022, which was the donor of the cornea tested reactive for HIV-1/HIV-2 Plus O antibody and non-reactive for HIVI/II NAT. The March 18, 2022, letter also informed customers that the FDA is recommending that the implanting physician share this notification with the recipients of these grafts, and is recommending that the recipients of these tissue grafts be counselled and tested for anti-HIV-1 and anti-HIV-2 and HIV NAT.
- Surgeons who used the affected lot/products should direct their questions or concerns to the company.
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Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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