Facility

BOSTON FOUNDATION FOR SIGHT/BostonSight TECH

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—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)	3006204913
Establishment type	Manufacture Medical Device
Location	464 Hillside Avenue Needham Hgts, MA, US 02494
Registration status	Active · expires 2026
Parent company	Boston Foundation for Sight (owner-operator 10027307)
Brand names	BostonSight PROSE; BostonSight SCLERAL

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Lens, Contact (Other Material) - Daily
Product code HQD (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.5916

Recalls & enforcement

Class IICompleted2025-06-10
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

FDA inspections (1)

NAI2017-09-28
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Boston Foundation for Sight

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. “BOSTON FOUNDATION FOR SIGHT/BostonSight TECH (FEI 3006204913) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006204913-boston-foundation-for-sight-bostonsight-/

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