CORNEAT VISION, LTD.: CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

Hazard

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Details from the source

Reason for recall: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong. Quantity: 630 units Lot/code info: All Lots/ UDI: G16010362950

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.