Sensar and Tecnis IOL Various (2016-08-30) — recall 55950
Health Canada — Medical Devices · Canada · 2016-08-30 · Type II
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Reported risk: AMO is initiating this action due to detection of an inspection equipment malfunction that resulted in a total of 58 distributed lenses not being fully checked prior to release. It has been identified that this malfunction may result in the release of mislabelled intraocular lenses. Use of a mislabelled intraocular lens could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention. Intraocular lenses with serial numbers included in the recall letter that have been implanted and resulted in an appropriate post-op refractive outcome are not affected by this action.
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