Z-0735-2024Class II

TECNIS Toric II OptiBlue IOL Models ZCW

Name: Z-0735-2024 TECNIS Toric II OptiBlue IOL Models ZCW
Creator: Johnson & Johnson Surgical Vision, Inc.
Published: 2023-12-12
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2023-12-12 / Open, Classified

FDA source

Johnson & Johnson Surgical Vision, Inc. began a recall of TECNIS Toric II OptiBlue IOL Models ZCW on 2023-12-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0735-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-12
Posted: 2024-01-16
Recalling firm: Advanced Medical Optics, Inc.
Product: TECNIS Toric II OptiBlue IOL Models ZCW
Product code: MJP Lens, Intraocular, Toric Optics
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.
FDA 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 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.
Quantity in commerce: 36
Distribution: International distribution to the country of Japan.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0735-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0735-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-16

Product code MJP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)