Recall Z-0735-2024 ยท MJP Lens, Intraocular, Toric Optics
Johnson & Johnson Surgical Vision, Inc.
TECNIS Toric II OptiBlue IOL Models ZCW
| Date | Jan 16, 2024 (initiated Dec 12, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | On or about 12/12/2023, the firm send an "URGENT: MEDICAL DEVICE RECALL" Letter via hand-delivery to customer/distributors informing that Johnson & Johnson Vision is initiating an Action due to the identification of a limited quantity of TECNIS Toric II OptiBlue IOLs in which the cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks. Customer are instructed to: 1.Identify if any of their inventory contains TECNIS Toric II OptiBlue IOLs from the list on page 5. 2.Remove all affected IOLs from their invento |
| Quantity | 36 |
| Distribution | International distribution to the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.