Recall Z-1177-2016— Volk Optical Inc
Class III · Terminated
Class III FDA medical device recall by Volk Optical Inc, initiated 2016-02-02, terminated 2017-04-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities. Reason: The firm discovered that the incorrect lot number was engraved on the product..
- Recalling firm
- Volk Optical Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-02-02
- Terminated
- 2017-04-26
- Firm location
- Mentor, OH, United States
Product description
Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
Reason for recall
The firm discovered that the incorrect lot number was engraved on the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.