BostonSight PROSE Contact Lenses recalled for optical and fit defects
Select batches of BostonSight PROSE contact lenses were manufactured with errors affecting optical properties and lens fit. Affected units have been identified by serial number.
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: FDA Class II medical device recall due to manufacturing defects affecting lens optics and fit, with no reported illnesses or injuries. This qualifies as a risk-of-harm product where injury has not yet been reported, as defects in lens fit and optical properties could compromise device function and patient safety.
Plain-English summary
Boston Foundation For Sight has recalled select orders of BostonSight PROSE contact lenses due to manufacturing errors that impact sagittal height (optical properties) and/or haptics (lens fit). A total of 38 units are affected by this recall.
The affected lenses were distributed worldwide, including throughout the United States and Canada. Patients who received these lenses can identify whether theirs are affected by checking their lens serial number against the specific lot numbers listed in this recall.
If you have received a BostonSight PROSE lens that matches one of the affected serial numbers, contact Boston Foundation For Sight immediately. Do not use the lens if it is identified as part of this recall. Consult with your eye care provider for a replacement lens.
The recalled product
- Product
- BostonSight PROSE Lens.
- Manufacturer
- Boston Foundation For Sight
- Category
- Medical Device — Contact Lens
- Hazard
- manufacturing-defect
- lens-fit-error
- optical-error
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: 534720
- 536887
- 540283. 2. UDI Number [Lot Number]
- Serial Numbers: (01)00785811435639(10)24214004 [24214004] Serial Numbers: 536327
- 537399
- 538805. 4. UDI Number [Lot Number]
- Serial Numbers: (01)00865576000201(10)F2402477 [F2402477] Serial Numbers: 532389
- 532390
- 532660
- 532666
- 532816
- 533417
- 533418
- 533419
- 533420. 7. UDI Number [Lot Number]
- Serial Numbers: (01)00865576000201(10)F2403286 [F2403286] Serial Numbers: 534129
- 534130
- 535028
- 535029
Distribution
Distributed nationwide across the United States.
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