Recall Monitor
Health Products

B-Sight SCLERAL

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Ophthalmology
Product: B-Sight SCLERAL
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
B-Sight SCLERAL532311BSSEII
B-Sight SCLERAL532602BSSINF
B-Sight SCLERAL533054BSSINF
B-Sight SCLERAL533056BSSINF
B-Sight SCLERAL533708BSSINF
B-Sight SCLERAL533918BSSINF
B-Sight SCLERAL533922BSSINF
B-Sight SCLERAL533375BSSINF
B-Sight SCLERAL534240BSSOXA
B-Sight SCLERAL532393BSSOXA
B-Sight SCLERAL531633BSSOXA
B-Sight SCLERAL532519BSSOXA
B-Sight SCLERAL532520BSSOXA
B-Sight SCLERAL533063BSSOXA
B-Sight SCLERAL533111BSSOXM
B-Sight SCLERAL534146BSSOXM
B-Sight SCLERAL532996BSSX02
B-Sight SCLERAL533415BSSX02

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

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