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SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER IO (2015-06-01)
- Starting date:
- June 1, 2015
- Posting date:
- August 24, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54724
Affected Products
A. SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER IO
Reason
Based on a limited number of complaints received for broken Haptics during lens loading and insertion, an investigation was initiated. This investigation resulted in Bausch & Lomb determining that a portion of a lot of Haptic material is performing differently than other lots in term of material elongation properties.
Affected products
A. SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER IO
Lot or serial number
> 1000 contact Manufacturer
Model or catalog number
LI61AO
LI61SE
Companies
- Manufacturer
-
Bausch and Lomb Inc.
1400 NORTH GOODMAN STREET
Rochester
14609
New York
UNITED STATES