Facility

NOVAVISION, INC.

1 recall(s) on record — most severe on record: Class I.

Key facts

1recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004594297
Establishment type	Manufacture Medical Device
Location	951 BROKEN SOUND PKWY STE 320 BOCA RATON, FL, US 33487
Registration status	Active · expires 2026
Parent company	VYCOR MEDICAL INC (owner-operator 9085664)
Brand names	NovaVisin VRT (Visual Restoration Therapy)

Activity by year

Recalls (1)

Devices registered here (1)

Perimeter, Automatic, Ac-Powered
Product code HPT (opens in a new tab) · Class I · Ophthalmic · 21 CFR 886.1605

Recalls & enforcement

Class ITerminated2012-08-21
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NOVAVISION, INC. (FEI 3004594297) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004594297-novavision-inc/

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