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T-flex Aspheric 573T (2015-12-31)
- Starting date:
- December 31, 2015
- Posting date:
- January 25, 2016
- 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-56814
Affected Products
T-flex Aspheric 573T
Reason
Internal quality checks have revealed that certain products released to market may contain a higher than usual level of residual polishing compound (aluminium oxide) that is used in the manufacturing process of intraocular lenses (IOLs). Rayner maintains extremely high levels of product quality and has set stringent internal limits for residual aluminium oxide levels. There is a possibility that certain products released to market may contain levels that slightly exceed these limits.
Affected products
T-flex Aspheric 573T
Lot or serial number
115E7733001
Model or catalog number
573T
Companies
- Manufacturer
-
Rayner Intraocular Lenses Ltd.
1-2 SACKVILLE TRADING ESTATE, SACKVILLE ROAD
SUSSEX
UNITED KINGDOM