TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
- Recall Initiated
- January 27, 2021
- Terminated
- November 9, 2022
- Recall Number
- Z-1163-2021
- Quantity
- 27 lenses
- Firm Location
- Santa Ana, CA
Reason for Recall
Due to the release of nonconforming Intraocular Lenses (IOLs).
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.
Lot / Code Info
Model Number: ZCT150 UDI/GTIN Codes: (01)05050474552210(17)221123(21)8144121847 5050474552210 Lot Number: 8144121847
Root Cause
Process change control
Action Taken
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 end of each individual unit carton (see page 3 for label example). 2) Discontinue using and remove from their inventory all affected IOLs. 3) Complete and return the attached Customer Reply Form to acknowledge receipt of this Recall Notice, even if they have no inventory. The Recalling Firm requires this information for reconciliation purposes with regulatory agencies. The Recalling Firm has pre-filled the Customer Reply Form with the IOL serial number(s) that was(were) shipped to them and marked accordingly where product has already been returned. The completed Customer Reply Form should be emailed to RegCompliOne@its.jnj.com or faxed to 1-714-460-0466 within 3 business days of receipt of the recall notification letter. 4) Should customers have product to return with the serial number listed on page 3, they are asked to contact Customer Support at 1-877-266-4543 to arrange pick up of affected product. 5) The Recall Notification Letter should be shared with anyone who needs to be aware within the customer's organization or to any organization where the potentially affected products have been transferred. Any questions contact the Public Contact/Director, Quality Assurance at 949-480-7526 or email jturpins@its.jnj.com