Home › OCULUS SURGICAL INC › SUPER VIEW Lens, Disposable Contact, Tornambe
SUPER VIEW Lens, Disposable Contact, Tornambe
OCULUS SURGICAL INC · Model 40413 · UDI-DI 00856222004209
HJK
Prescription
1
510(k) clearances
9
Adverse events
3
Recalls
28
Facilities
Description
SUPER VIEW Tornambe Disposable Contact Lens for use visualizing the fundus during vitreo-retinal surgery.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
| 2016-02-02 | Volk Optical Inc | The firm discovered that the incorrect lot number was engraved on the product. |
| 2015-02-27 | Volk Optical Inc | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.