TECNIS Toric II OptiBlue IOL Models ZCW
- Recall Initiated
- December 12, 2023
- Posted
- January 16, 2024
- Recall Number
- Z-0735-2024
- Quantity
- 36
- Firm Location
- Irvine, CA
Reason for Recall
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.
Distribution
International distribution to the country of Japan.
Lot / Code Info
Model Numbers: ZCW375 UDI code: N/A (not distributed in the U.S.) Serial Numbers: 3473902107 3473912107 3473922107 3473932107 3473942107 3473952107 3473962107 3473972107 3474002107 3474012107 3474022107 3474072107 3474082107 3474092107 3474102107 3474112107 3474122107 3474132107 3474152107 3474162107 3474172107 3474182107 3474192107 3474202107 3474222107 3474232107 3474242107 3474252107 3474262107 3474282107 3474292107 3474312107 3474322107 3474332107 3474342107 3474352107
Root Cause
Under Investigation by firm
Action Taken
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 inventory. 3.Complete the attached Customer Reply Form. The firm requires this information for reconciliation purposes with regulatory agencies, even if you have no inventory. If customers have product to be returned: Complete the Customer Reply Form, noting the serial number of the TECNIS Toric II OptiBlue IOLs. "Contact Customer Support to obtain an RGA number and arrange product return. "Email Customer Reply Form within 3 business days of receipt of this letter. "Return affected product as soon as possible. A credit will be issued upon receipt of the customer reply form and product. If customer does not have product to be returned: " Review patient records to confirm implantation of the impacted lens. " If no unexpected postoperative outcome occurred following the implantation of the TECNIS Toric II OptiBlue, no further action is required after Customer Reply Form has been returned. " If issues were encountered, please inform JJSV. If customer is reporting a complaint, provide the serial number, the date of surgery, a description of the event, and patient outcome. " Complete and return the Customer Reply Form and email within 3 business days of receipt of this letter.