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An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.
As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.
Product has a misbranded Yellow Color. Identified on label at Artificial Yellow Color , and it should be identified as FD&C Yellow #5