Product Wiki · Recalls · Health Canada — Medical Devices

T-Flex Aspheric 623T — recall 49275

Health Canada — Medical Devices · Canada · 2012-12-24 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 49275
Date of alert: 2012-12-24
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: 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.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/t-flex-aspheric-623t

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T-Flex Aspheric 623T — recall 49275

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