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Recall Observatory FDA recall evidence

Device product

BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).

Z-1066-2019

November 30, 2018

Class II

Product summary

Firm
Beaver Visitec
Event
Event 81757
Status
Terminated
Classification
Class II
Quantity
3430 units
Official record key
device-enforcement:Z-1066-2019

Official wording

Reason: Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.

Code information: Lots 60047S4, 60060S9, 600623S

Distribution pattern: Worldwide distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, GA, LA, MD, MO, NC, NE, NJ, NY, OH, OK, TX, UT, VA, WA; and countries of: Mexico and Peru.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.