Intraocular Lens Cylinder Axis Marks Out of Specification
Johnson & Johnson is recalling TECNIS Toric II intraocular lenses distributed in Japan. The cylinder axis marks do not meet product specifications and could affect vision correction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a manufacturing specification defect affecting a medical device used in vision correction. No illnesses, injuries, or hospitalization reports have been documented. The defect poses a risk to proper lens function without yet causing reported harm, meeting the High severity criterion for risk-of-harm products where injury has not been reported.
Plain-English summary
Johnson & Johnson Surgical Vision, Inc. is recalling TECNIS Toric II OptiBlue intraocular lenses (Model ZCW375) distributed to Japan. The recall affects 36 specific units identified by serial number.
The intraocular lens has cylinder axis marks that do not meet product specifications. The angle between the Low Power Meridian and the toric cylinder axis marks is out of specification, failing to conform to the product's allowable tolerances.
Toric intraocular lenses are used during cataract surgery to correct astigmatism. If the cylinder axis marks are not correctly aligned as specified, the lens may not provide the intended vision correction.
Patients who have received one of the recalled lenses should contact their eye care provider or the facility where the surgery was performed. Healthcare providers have been notified of the recall. Patients should not attempt to self-remove or replace the lens but should consult with their eye care professional about the appropriate course of action.
The recalled product
- Product
- TECNIS Toric II OptiBlue IOL Models ZCW
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
- Affected units
- 36
Distribution
Distribution scope not specified by the agency.
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