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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Contact Lenses & Vision

BostonSight SCLERAL and PROSE Lenses Recalled for Manufacturing Errors

Agency Publication Date: July 29, 2025
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Summary

Boston Foundation For Sight is recalling approximately 479 BostonSight SCLERAL and PROSE lenses due to errors in the manufacturing process. These errors impacted the sagittal height and haptics of the lenses, which are critical for ensuring a proper and comfortable fit on the eye. There have been no reported injuries or incidents related to this manufacturing defect.

Risk

If the sagittal height or haptics are incorrectly manufactured, the lens may not fit properly on the wearer's eye. This can cause discomfort, irritation, or vision problems for the patient.

What You Should Do

  1. This recall affects BostonSight SCLERAL and PROSE lenses with specific lot and serial numbers manufactured by Boston Foundation For Sight.
  2. Check your lens packaging or patient records to see if your lot number or serial number matches the recalled units. See the Affected Products section below for the full list of affected codes.
  3. Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or the manufacturer for further instructions.
  4. Contact Boston Foundation For Sight directly if you have questions about returning or replacing your specific lenses.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: BostonSight SCLERAL Lens
Serial Numbers (441):
533161
533366
534227
534270
534852
535467
535738
536062
536078
536201
536463
536661
532311
533233
533327
533329
533685
534355
535382
535656
536029
536645
532344
532388
532505
532770
532996
533075
533240
533400
533415
533488
534201
534368
534853
535050
535386
535468
536080
536893
533000
533015
533158
533291
533292
531283
531284
532900
532975
533241
Lot Numbers:
24341007
24159006
24214004
24043010
24183007
24270004
F2402477
F2403286
F2403377
F2500084
F2500102
F2500351
F2000255
F2203214
F2300341
F2301495
F2402189
F2402243
F2402750
F2403494
F2500310
F2500408
UDI:
00785811435077
00785811435639
00785811435677
00865576000201
00865576000218
00865576000294

Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

Product: BostonSight PROSE Lens
Serial Numbers:
534720
536887
540283
534761
536327
537399
538805
535453
540811
532389
532390
532660
532666
532816
533417
533418
533419
533420
534129
534130
535028
535029
535711
535712
535869
536897
537916
537918
538203
533357
533358
539865
535908
532817
534107
536034
540171
539392
Lot Numbers:
24341007
20030007
24214004
22078002
24183007
F2402477
F2403286
F2403377
)T020007
F2300341
F2402750
F2403018
F2500408
UDI:
00785811435077
00785811435639
00785811435677
00865576000201
00865576000218
00865576000294

Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97123
Status: Active
Manufacturer: Boston Foundation For Sight
Sold By: Eye care providers; Specialty clinics
Manufactured In: United States
Units Affected: 2 products (441 units; 38 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.