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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 64356
Product Type Biologics
Status Terminated
Recalling Firm Sight Society of Northeastern New York Lions Eye Bank@Albany
City Albany
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-18
Initial Firm Notification of
Consignee or Public
Distribution Pattern New York

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Human Cornea for Transplant Preserved in Optisol GS --- Single Patient Use --- Lions Eye Bank at Albany 518-489-7606 NY1301009 R1 (Right) and NY1301009 L1 (Left); Class II Human Corneas, not tested to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. 2 corneas (1 left, 1 right) B-2340-13