Reported Aug 6, 2025 · Ongoing

BostonSight SCLERAL Lens

Boston Foundation For Sight

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Foundation For Sight · 464 Hillside Ave Ste 205 · Needham, MA · 02494-1228

Is this the product you have?

  • BostonSight SCLERAL Lens
Lot codes and dates
  • 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)24159006 [24159006]
  • Serial Number532311. 3. UDI Number [Lot Number]
  • Serial Numbers(01)00785811435639(10)24214004 [24214004]
  • Serial Numbers
    • 533233
    • 533327
    • 533329
    • 533685
    • 534355
    • 535382
    • 535656
    • 536029
    • 536645. 4. UDI Number [Lot Number]
  • Serial Numbers(01)00785811435677(10)24043010 [24043010]
  • Serial Numbers
    • 532344
    • 532388
    • 532505
    • 532770
    • 532996
    • 533075
    • 533240
    • 533400
    • 533415
    • 533488
    • 534201
    • 534368. 5. UDI Number [Lot Number]
  • Serial Numbers(01)00785811435677(10)24183007 [24183007]
  • Serial Numbers
    • 534853
    • 535050
    • 535386
    • 535468
    • 536080
    • 536893. 6. UDI Number [Lot Number]
  • Serial Numbers(01)00785811435677(10)24270004 [24270004]
  • Serial Numbers
    • 533000
    • 533015
    • 533158
    • 533291
    • 533292. 7. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000201(10)F2402477 [F2402477]
  • Serial Numbers
    • 531283
    • 531284
    • 532900
    • 532975
    • 533241. 8. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000201(10)F2403286 [F2403286]
  • Serial Numbers
    • 533201
    • 533597
    • 533598
    • 533736
    • 533805
    • 533806
    • 534082
    • 534131
    • 534132
    • 534248
    • 534249
    • 534912
    • 534998
    • 534999
    • 535022
    • 535084
    • 535185
    • 536175
    • 536179
    • 536203
    • 536740
    • 537148. 9. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000201(10)F2403377 [F2403377]
  • Serial Numbers

    125 of 125 codes

    • 529720
    • 532304
    • 532321
    • 532329
    • 532330
    • 532357
    • 532359
    • 532370
    • 532391
    • 532393
    • 532519
    • 532520
    • 532557
    • 532589
    • 532648
    • 532670
    • 532677
    • 532790
    • 532824
    • 532853
    • 532878
    • 532889
    • 532910
    • 532925
    • 532970
    • 532984
    • 533063
    • 533130
    • 533342
    • 533361
    • 533372
    • 533374
    • 533401
    • 533537
    • 533553
    • 533588
    • 533607
    • 533700
    • 533862
    • 533876
    • 533891
    • 533906
    • 533930
    • 533964
    • 533989
    • 533993
    • 533994
    • 534026
    • 534029
    • 534108
    • 534121
    • 534149
    • 534161
    • 534163
    • 534171
    • 534180
    • 534231
    • 534239
    • 534240
    • 534267
  • Serial Numbers(01)00865576000201(10)F2500084 [F2500084]
  • Serial Numbers
    • 531633
    • 532283
    • 532334
    • 532368
    • 532503
    • 532583
    • 532662
    • 532675
    • 532700
    • 532731
    • 532732
    • 532741
    • 532886
    • 532891
    • 532930
    • 532944
    • 532983
    • 533080
    • 533085
    • 533175
    • 533227
    • 533434
    • 533436
    • 533464
    • 533466
    • 533484
    • 533662
    • 533714
    • 533715
    • 533738
    • 533793
    • 533835
    • 533856
    • 534667
    • 534776
    • 534889
    • 534993
    • 535174
    • 535176
    • 535316
    • 535370
    • 535406
    • 535407. 11. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000201(10)F2500102 [F2500102]
  • Serial Numbers
    • 527131
    • 535133
    • 535413
    • 535501
    • 535609
    • 535610
    • 535734
    • 535735
    • 535813
    • 535814
    • 535828
    • 535834
    • 535982
    • 535983
    • 536001
    • 536071
    • 536111
    • 536143
    • 536145
    • 536229
    • 536299
    • 536455
    • 536472
    • 536604
    • 536726
    • 536728
    • 536871
    • 536872
    • 536923. 12. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000201(10)F2500351 [F2500351]
  • Serial Numbers537344. 13. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000218(10)F2000255 [F2000255]
  • Serial Numbers
    • 533111
    • 533245
    • 533773
    • 534049
    • 534084
    • 534213
    • 536907. 14. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000218(10)F2203214 [F2203214]
  • Serial Numbers
    • 532833
    • 532841
    • 533614
    • 533615
    • 533616
    • 533617
    • 533618
    • 533620
    • 533621
    • 533622. 15. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000218(10)F2300341 [F2300341]
  • Serial Numbers
    • 533735
    • 535512. 16. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000218(10)F2301495 [F2301495]
  • Serial Numbers
    • 532888
    • 533495
    • 533534
    • 533612
    • 533754
    • 533920
    • 534037
    • 534041
    • 534058
    • 534060
    • 534092
    • 534095
    • 534146
    • 534157
    • 534158. 17. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000218(10)F2402189 [F2402189]
  • Serial Numbers
    • 532640
    • 533502
    • 533613
    • 533619
    • 534929
    • 534930
    • 534933
    • 534934
    • 534936
    • 534951
    • 534952
    • 535134
    • 535153
    • 535724
    • 535725
    • 535728
    • 535775
    • 535776
    • 535788
    • 535789
    • 535796
    • 535827
    • 535829
    • 535830
    • 535929
    • 536031
    • 536079
    • 536081
    • 536711
    • 536713
    • 536714. 18. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000218(10)F2402243 [F2402243]
  • Serial Numbers
    • 534279
    • 534280
    • 534424
    • 534507
    • 534624
    • 534634
    • 534636
    • 534637
    • 534638
    • 534639
    • 534641
    • 534642
    • 535122
    • 535727
    • 535771
    • 535772
    • 535773
    • 535964
    • 536257
    • 536809. 19. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000294(10)F2402750 [F2402750]
  • Serial Numbers
    • 527418
    • 533310
    • 533313
    • 533477
    • 533653
    • 534242
    • 534411
    • 534621
    • 534824
    • 535020
    • 535096
    • 535241
    • 535559
    • 535648
    • 535649
    • 536137
    • 536716
    • 536929
    • 536933
    • 536959
    • 536964
    • 536965
    • 536966
    • 537062. 20. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000294(10)F2403494 [F2403494]
  • Serial Numbers
    • 532559
    • 532564
    • 532758
    • 532811
    • 532901
    • 532903
    • 532935
    • 532953
    • 533344
    • 533375
    • 533918
    • 534895
    • 536387
    • 536465
    • 536466
    • 536698
    • 536862. 21. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000294(10)F2500310 [F2500310]
  • Serial Numbers
    • 529303
    • 529304
    • 532406
    • 532413
    • 532416
    • 532600
    • 532602
    • 532624
    • 532759
    • 532780
    • 532868
    • 532897
    • 533054
    • 533056
    • 533156
    • 533194
    • 533567
    • 533708
    • 533866
    • 533884
    • 533922
    • 533955
    • 534218
    • 534219
    • 534345
    • 534367
    • 534375
    • 534390
    • 534492
    • 534740
    • 534742
    • 534810
    • 534893
    • 535278
    • 535342
    • 535497
    • 535715
    • 536035
    • 536380. 22. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000294(10)F2500408 [F2500408]
  • Serial Numbers
    • 532828
    • 532831
    • 536432
    • 536433
    • 536827
    • 537061
Amount recalled
441 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.