Recall Z-1685-2015— Volk Optical Inc

Name: FDA recall Z-1685-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-27

Class III · Terminated

Class III FDA medical device recall by Volk Optical Inc, initiated 2015-02-27, terminated 2016-02-19. It names one FDA 510(k) clearance: K023221. Product: Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.. Reason: Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring..

Recalling firm: Volk Optical Inc
Classification: Class III
Status: Terminated
Initiated: 2015-02-27
Terminated: 2016-02-19
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K023221 — CONTACT LASER & DIAGNOSTIC LENSESVolk Optical, Inc.·cleared 2002-10-11

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

Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

Reason for recall

Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.

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