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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