BVI Safety Knife

Manufacturer received feedback from a singular customer that the wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down). There was no injuries or illnesses reported in connection to the associated failure mode.

Inadvertently, using a bevel down blade instead of a bevel-up blade causes the surgeon to make an unintended incision architecture. A careful, observant surgeon is likely to notice the incorrect blade orientation under the microscope prior to use. However, when unnoticed, the unintended incision architecture potentially leads to an incision leakage. When incision leakage goes unnoticed , a watertight wound closure may not be achieved and thereby increasing the risk for anterior chamber fluid egress or ocular surface fluid ingress. Health effects include infection, iris prolapse, and intraocular pressure (IOP) fluctuations.

Recall start date: May 10, 2024