TECNIS Toric II OptiBlue IOL Models ZCW

FDA device recall Z-0735-2024 · posted 2024-01-16 · Open, Classified

Recall details

Recalling firm

Johnson & Johnson Surgical Vision, Inc.

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.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MJP

Quantity affected

36

Distribution

International distribution to the country of Japan.

Date initiated

2023-12-12

Date posted

2024-01-16

Location

Irvine, CA