Johnson & Johnson Surgical Vision, Inc. is recalling 36 units of the TECNIS Toric II OptiBlue Intraocular Lens (IOL) Model ZCW375. These lenses, used during eye surgery, have cylinder axis marks that do not meet accuracy specifications for the angle between the Low Power Meridian and the toric cylinder axis. Because these marks are used by surgeons to align the lens correctly during implantation, the defect could lead to improper positioning of the lens in a patient's eye. If you have had one of these specific lenses implanted, you should contact your healthcare provider or the manufacturer for further instructions.
The misalignment of the axis marks on the lens can lead to the device being rotated or positioned incorrectly during surgery. This can result in suboptimal vision correction or other surgical complications for the patient.
Manufacturer notification via letter
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.