CyPass System Model 241-S

• 4 recalls, same reason

  • Terminated Z-0187-2019 FDA Class I ·initiated 28 Aug 2018
  • Terminated Z-0188-2019 FDA Class I ·initiated 28 Aug 2018
  • Terminated Z-0185-2019 FDA Class I ·initiated 28 Aug 2018
  • Terminated Z-0186-2019 FDA Class I ·initiated 28 Aug 2018

  Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.

Full name

Cypass System

Trade Name

CyPass Micro-Stent

Generic Name

Intraocular pressure lowering implant

PMA Number

P150037 ↗

FDA Product Code

OGO

Device Class

Class III

Advisory Committee

Ophthalmic

FDA Decision

APWD Approval withdrawn

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  Class II

  FDA 510(k) K050729 Active Cleared 14 Sep 2005

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  Class I

  FDA 510(k) K062930 Active Cleared 8 Nov 2006

• Clearcut S Safety Knife Open recall

  Class I

  FDA 510(k) K110166 Active Cleared 20 May 2011

• CENTURION Vision System (Active SentryTM)

  Class II

  FDA 510(k) K161794 Active Cleared 14 Apr 2017

• Monarch II IOL Delivery System

  Class I

  FDA 510(k) K001157 Active Cleared 27 Jun 2000

• Wavelight FS200 Laser System Model: FS200

  Class II

  FDA 510(k) K101006 Active Cleared 21 Oct 2010

See all devices from Alcon Research, Ltd. →