Health product recall

B-Sight SCLERAL

Last updated

Summary

Product
B-Sight SCLERAL
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

B-Sight SCLERAL

532311

BSSEII

B-Sight SCLERAL

532602

BSSINF

B-Sight SCLERAL

533054

BSSINF

B-Sight SCLERAL

533056

BSSINF

B-Sight SCLERAL

533708

BSSINF

B-Sight SCLERAL

533918

BSSINF

B-Sight SCLERAL

533922

BSSINF

B-Sight SCLERAL

533375

BSSINF

B-Sight SCLERAL

534240

BSSOXA

B-Sight SCLERAL

532393

BSSOXA

B-Sight SCLERAL

531633

BSSOXA

B-Sight SCLERAL

532519

BSSOXA

B-Sight SCLERAL

532520

BSSOXA

B-Sight SCLERAL

533063

BSSOXA

B-Sight SCLERAL

533111

BSSOXM

B-Sight SCLERAL

534146

BSSOXM

B-Sight SCLERAL

532996

BSSX02

B-Sight SCLERAL

533415

BSSX02

Issue

A specific number of b-sight scleral lenses were not manufactured to practitioners sagittal depth and haptic specifications. we are requesting users return the affected lenses.

Recall start date: June 10, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ophthalmology
Companies

Boston Foundation For Sight, Inc. Dba Bostonsight

464 Hillside Avenue, Needham, Massachusetts, United States, 02494

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77664

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