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T-Flex Aspheric 623T
- Starting date:
- November 7, 2012
- Posting date:
- December 24, 2012
- 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-25855
Recalled Products
- T-Flex Aspheric 623T
Reason
Potential sterility failure of the paper pouch (supplied to Rayner by an external company) that surrounds the intraocular lens blister tray. A failed pouch seal may cause the patient permanent serious injury and may cause severe infection and/or contribute to the development of Toxic Anterior Segment Syndrome (TASS). TASS can cause serious damage to intraocular tissues, resulting in vision loss.
Affected products
A. T-Flex Aspheric 623T
Lot or serial number
102E4207203, 102E4207204
Model or catalog number
623T
Companies
- Manufacturer
- Rayner Intraocular Lenses Ltd.