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BostonSight PROSE

The Boston Foundation For Sight, Inc. · Model 02 · UDI-DI 10850085735239

HQD Prescription
1
510(k) clearances
134
Adverse events
5
Recalls
36
Facilities

Description

BostonSight PROSE for daily wear, fabricated from Optimum Extra (roflufocon D) - Clear- THP coated

Recalls

DateFirmReason
2025-06-10Boston Foundation For SightSelect orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
2025-06-10Boston Foundation For SightSelect orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
2018-07-03Alden OpticalVials labeled for the prescriptions contained incorrect lenses
2018-07-03Alden OpticalVials labeled for the prescriptions contained incorrect lenses
2010-04-20Bausch & Lomb IncThe amount of D&C #6 Dye added to the formulation exceeded specified amounts.

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Data 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.