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  5. Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338
  1. Recalls (Biologics)

Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338

Firm:
CorneaGen
1200 6th Ave
Suite 300
Seattle, WA 98101
T: 206-701-5840

Lot Number: W419221008338

Product Numbers: W419221008338005; W419221008338006; W419221008338007; W419221008338008; W419221008338009; W419221008338010; W419221008338011; W419221008338012; W419221008338013; W419221008338014; W419221008338015; W419221008338016; W419221008338017; W419221008338018; W419221008338019

On January 5, 2022, CorneaGen discovered that Scleral Patch Grafts (Lot Number WA419221008338) were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and HIV NAT, and were shipped prior to being medically cleared. CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338.

CorneaGen issued a Product Recall Letter dated January 11, 2022. This notification instructs customers who received Scleral Patch Grafts to review the product lot information and if any affected product remains within their facility to contact the CorneaGen distribution department at bal.tissue@corneagen.com or at 1-800-858-2020 to schedule a return and replacement.

ConreaGen issued a second notification letter dated March 18, 2022. This notification informed customers of the reason for the letter dated January 11, 2022 which was the donor of the grafts tested reactive for HIV-1/HIV-2 Plus O antibody and reactive for HIV 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 Christina Cooper at christina.cooper@corneagen.com or (206) 278-8274.

The information in this listing reflects CBER’s best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed

 
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