Boston Foundation For Sight recalls BostonSight SCLERAL Lens
Reason for recall
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- BostonSight SCLERAL LensUDI Number400 affected lots533161533366534227534270534852535467535738536062
+392 more
536078536201536463536661532311533233533327533329533685534355535382535656536029536645532344532388532505532770532996533075533240533400533415533488534201534368534853535050535386535468536080536893533000533015533158533291533292531283531284532900532975533241533201533597533598533736533805533806534082534131534132534248534249534912534998534999535022535084535185536175536179536203536740537148529720532304532321532329532330532357532359532370532391532393532519532520532557532589532648532670532677532790532824532853532878532889532910532925532970532984533063533130533342533361533372533374533401533537533553533588533607533700533862533876533891533906533930533964533989533993533994534026534029534108534121534149534161534163534171534180534231534239534240534267534269534276534287534304534332534382534421534451534452534476534516534536534537534588534590534591534606534613534614534616534617534649534709534710534716534718534848534873534874534981535013535098535137535138535145535182535196535318535328535335535347535351535372535455535459535945535947535963535965535967535977536009536066536070536105536138536178536222536223536429536669536771536772537001537028531633532283532334532368532503532583532662532675532700532731532732532741532886532891532930532944532983533080533085533175533227533434533436533464533466533484533662533714533715533738533793533835533856534667534776534889534993535174535176535316535370535406535407527131535133535413535501535609535610535734535735535813535814535828535834535982535983536001536071536111536143536145536229536299536455536472536604536726536728536871536872536923537344533111533245533773534049534084534213536907532833532841533614533615533616533617533618533620533621533622533735535512532888533495533534533612533754533920534037534041534058534060534092534095534146534157534158532640533502533613533619534929534930534933534934534936534951534952535134535153535724535725535728535775535776535788535789535796535827535829535830535929536031536079536081536711536713536714534279534280534424534507534624534634534636534637534638534639534641534642535122535727535771535772535773535964536257536809527418533310533313533477533653534242534411534621534824535020535096535241535559535648535649536137536716536929536933536959536964536965536966537062532559532564532758532811532901532903532935532953533344533375533918534895536387536465536466536698536862529303529304532406532413
What the firm is doing
Consignees were notified via email with the subject "URGENT: BostonSight SCLERAL- Recall of Selected Orders". Consignees are to return affected devices to BostonSight via the prepaid envelopes that are to be provided. Replacement units will be provided, and the firm will be in contact with information regarding replacements. Consignees with any questions are to contact Laurel Villers by email at LVillers@Bostonsight.org or by phone at 781-726-7436.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Canada.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2190-2025
- FDA 510(k) clearance · K183175The device's official FDA premarket clearance record
- FDA device classification · HQDOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.5916The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Foundation For SightSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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