Despite multiple requests for additional information, ocular therapeutix (otx) has not received additional information.Otx does not have any information on the physician(s) who applied resure, the patients who may have experienced endophthalmitis, if serious injury occurred, or if the physician(s) believe resure sealant caused or contributed to the injury.Based on this information, there is insufficient information for us to determine if there is a change to the risk profile of resure.Follow-up reports will be submitted in accordance with 21 cfr part 803.56 if additional information is obtained.
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