Class II
Medical Device Recall: TECNIS Toric II OptiBlue IOL Models ZCW
Johnson & Johnson Surgical Vision, Inc. · December 12, 2023
Reason for Recall
Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
Distribution
International distribution to the country of Japan.
Quantity Affected
36
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0735-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.