BostonSight Scleral Contact Lenses Recall Due to Manufacturing Defects
Boston Foundation For Sight is recalling 441 units of BostonSight SCLERAL contact lenses manufactured with errors affecting lens height and edge fit parameters.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving structural manufacturing defects in contact lenses that directly contact the eye. Manufacturing errors affecting sagittal height and haptics parameters create a risk of improper lens fit. No reported illnesses or injuries are mentioned in the source material, which limits the severity to High rather than Severe.
Plain-English summary
Boston Foundation For Sight is recalling 441 units of BostonSight SCLERAL scleral contact lenses. The lenses were manufactured with errors impacting sagittal height (the dome or curvature of the lens) and/or haptics (the edge portions that rest on the eye).
The affected lenses were distributed worldwide, including throughout the United States and Canada. The recall applies to specific serial numbers and lot numbers detailed in the FDA recall notice.
The recalled product
- Product
- BostonSight SCLERAL Lens
- Manufacturer
- Boston Foundation For Sight
- Hazard
- manufacturing-defect
- improper-lens-fit
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. UDI Number [Lot Number]
- Serial Numbers: (01)00785811435077(10)24341007 [24341007] Serial Numbers: 533161
- 533366
- 534227
- 534270
- 534852
- 535467
- 535738
- 536062
- 536078
- 536201
- 536463
- 536661. 2. UDI Number [Lot Number]
- Serial Numbers: (01)00785811435639(10)24214004 [24214004] Serial Numbers: 533233
- 533327
- 533329
- 533685
- 534355
- 535382
- 535656
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03