BostonSight scleral lenses made with sagittal height or haptic errors
BostonSight SCLERAL Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 441 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a manufacturing dimensional error on custom lenses, with no clinical consequence stated in the source.
Plain-English summary
The BostonSight SCLERAL Lens is being recalled. The action covers 441 units, identified by the UDI numbers, lot numbers and serial numbers in the recall notice.
The stated reason is that select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was worldwide, including nationwide in the United States and to Canada.
Wearers and eye care practitioners should identify affected lenses using the UDI, lot and serial numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- BostonSight SCLERAL Lens
- Manufacturer
- Boston Foundation For Sight
- Category
- Medical Device — Scleral lens
- Hazard
- manufacturing-error
- sagittal-height
- haptics
- class-ii
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.
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