BostonSight SCLERAL Lens
Reported: August 6, 2025 Initiated: June 10, 2025 #Z-2190-2025
Product Description
BostonSight SCLERAL Lens
Reason for Recall
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Details
- Recalling Firm
- Boston Foundation For Sight
- Units Affected
- 441 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada.
- Location
- Needham, MA
Frequently Asked Questions
What product was recalled? ▼
BostonSight SCLERAL Lens. Recalled by Boston Foundation For Sight. Units affected: 441 units.
Why was this product recalled? ▼
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2025. Severity: Moderate. Recall number: Z-2190-2025.
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