Health product recall

BVI Safety Knife

Last updated

Summary

Product
BVI Safety Knife
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

BVI Safety Knife

6058854

378227

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ophthalmology
Companies
Beaver-Visitec International, Inc
500 Totten Pond Rd. - 10 Citypoint, Waltham, Massachusetts, United States, 02451
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75592

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