Recall Z-1163-2021 ยท MJP Lens, Intraocular, Toric Optics
Johnson & Johnson Surgical Vision Inc
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
| Date | Jan 27, 2021 |
| Status | Terminated |
| Reason | Due to the release of nonconforming Intraocular Lenses (IOLs). |
| Root cause | Process change control |
| Action | On 01/27/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via confirmed mail to customers informing them that due to investigation results, following a customer complaint, which confirmed a hyperopic patient outcome post implantation for an Intraocular Lens (IOL). The investigation for this complaint determined that this occurred due to inadvertent release of nonconforming product (Product labeled as 23.5D but measured to be 17.5D). Customers are instructed to: 1) Compare their inventory against the attached list on page 3. The IOL serial number is displayed on the en |
| Quantity | 27 lenses |
| Distribution | U.S. Nationwide distribution in the states of AL, AZ, CA, FL, GA, IL, LA, MI, MN, NC, NY, OH, PA, SC, TN, TX, UT and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.