Recall Z-0206-2016— Bausch & Lomb Inc Irb

Name: FDA recall Z-0206-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-03

Class II · Terminated

Class II FDA medical device recall by Bausch & Lomb Inc Irb, initiated 2015-09-03, terminated 2016-06-06. It names one FDA 510(k) clearance: K113703. Product: BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.. Reason: The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity..

Recalling firm: Bausch & Lomb Inc Irb
Classification: Class II
Status: Terminated
Initiated: 2015-09-03
Terminated: 2016-06-06
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K113703 — BAUSCH + LOMB NESOFILCON A CONTACT LENSBausch & Lomb, Incorporated·cleared 2012-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.

Reason for recall

The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.

Data sourced from openFDA. This site is unofficial and independent of the FDA.