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Staar Surgical Co.

www.staar.com

Latest From Staar Surgical Co.

Ophthalmic Panel To Eye Alcon’s AcrySof IQ Restor Multifocal IOL

FDA’s ophthalmic devices advisory panel plans to meet on Nov. 14 to assess Alcon Laboratories’ PMA application for its AcrySof IQ Restor multifocal toric posterior chamber intraocular lens.

Medical Device Regulation

Warning Letter Roundup & Recap

Staar Surgical faces quality system violations related to its Visian ICL and MICL intraocular lenses; MTI Precision Products didn’t notify FDA after it recalled TM20 hand pieces due to sharp nose edges; an employee responsible for elastic band production at Dexta Corp. was unable to answer questions about his job. Eight quality-related warning letters were listed by FDA from June 24 through July 7.

Medical Device Compliance

FDA Advisory Panel Supports Staar Surgical Visian Toric Lens

FDA’s Ophthalmic Devices Panel voted in favor of Staar Surgical’s Visian toric implantable collamer lens to correct myopic astigmatism in adults ages 21 to 45. Earlier safety and missing data questions on the lenses were reviewed, but ultimately, the panel said the product’s proposed indication outweighed risk for use in specified patients.

Medical Device Regulation

Regulatory Briefs: Open Data Website Launch; Upcoming FDA Meetings

FDA launches openFDA website to provide access to datasets. Agency announces upcoming Ophthalmic Devices and Risk Communications meetings. More regulatory briefs.

Medical Device
See All

Company Information

  • Industry
  • Biotechnology
  • Medical Devices
    • Biomaterials
    • Implantable Devices
    • Surgical Equipment & Devices
      • Minimally or Less Invasive
  • Therapeutic Areas
  • Ophthalmic
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Staar Surgical Co.
  • Senior Management
  • Caren Mason, Pres. & CEO
    Deborah Andrews, CFO
    Scott D Barnes, MD, CMO
    Robin Hughes, VP, Mktg.
  • Contact Info
  • Staar Surgical Co.
    Phone: (626) 303-7902
    1911 Walker Ave.
    Monrovia, CA 91016
    USA
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