Storz Millennium Microsurgicl System High Speed Vitrectomy System

• 2 recalls, same reason

  • Terminated Z-0766-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007
  • Terminated Z-0765-2007 FDA Unclassified (pre-2012) ·initiated 9 Feb 2007

  The cutter probe tip breaks during use.

• 2 recalls, same reason

  • Terminated Z-0495-2007 FDA Unclassified (pre-2012) ·initiated 14 Dec 2006
  • Terminated Z-0496-2007 FDA Unclassified (pre-2012) ·initiated 14 Dec 2006

  The cutter tip could break during a procedure

510(k) Number

K980488 ↗

FDA Product Code

HQE

Device Class

Class II

Regulation

21 CFR Part 886.4150

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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• Storz Premiere/Premiere Microvit Microsurg Systems

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