Device recall

Z-1705-2010: Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone…

FDA device recall · Class II · Bausch & Lomb Inc

Key facts

Recall number (Z-number) Z-1705-2010
Recall event 55538
Product Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Bausch & Lomb, Inc. Wilmington, MA 01887. Indicated for daily wear for the correction of refractive ametropia in aphakic and/or not-aphakic persons with non-diseased eyes.
Product code HQD
Recalling firm Bausch & Lomb Inc
Recall class Class II
Status Terminated
Termination date Apr 27, 2016
510(k) numbers K943177
FEI number 1317628

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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