Boston Foundation For Sight
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Boston Foundation For Sight makes
Boston Foundation For Sight manufactures specialized contact lenses, including the BostonSight IC Corneal Lens and BostonSight IC Scleral Lens, designed for ocular conditions.
These devices are classified as Class II and listed in the FDA 510(k) registry. The company is based in the US.
Catalogue
- 510(k) 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Boston Foundation For Sight, initiated on 2025-06-10. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 2
- 2026 0
2025
- 10 Jun 2025 Z-2190-2025 Class II Completed Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
- 10 Jun 2025 Z-2191-2025 Class II Completed Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Frequently asked questions
How many devices does Boston Foundation For Sight have in the registry?
The registry currently lists 1 device for Boston Foundation For Sight. Devices recorded under merged duplicate company entries are counted once.
Which registries list Boston Foundation For Sight's devices?
Among its 1 most recently registered device, Boston Foundation For Sight has devices listed in FDA 510(k) (1 device).
What risk classes do Boston Foundation For Sight's devices fall under?
Among its 1 most recently registered device, the classes recorded for Boston Foundation For Sight's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Boston Foundation For Sight?
FDA recall records list 2 recalls initiated by Boston Foundation For Sight, the most recent initiated on 2025-06-10. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Boston Foundation For Sight in the registry?
The most recently registered devices listed for Boston Foundation For Sight include BostonSight IC Corneal Lens, BostonSight IC Scleral Lens.