Recall Z-1033-2022— Johnson & Johnson Surgical Vision Inc

Name: FDA recall Z-1033-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-06

Class II · Ongoing

Class II FDA medical device recall by Johnson & Johnson Surgical Vision Inc, initiated 2022-04-06. It names one FDA 510(k) clearance: K951462. Product: TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,. Reason: Potential breach in the sterility barrier for tray ring covers..

Recalling firm: Johnson & Johnson Surgical Vision Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-04-06
Firm location: Santa Ana, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K951462 — AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEMAllergan Medical Optics·cleared 1995-06-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

Reason for recall

Potential breach in the sterility barrier for tray ring covers.

Data sourced from openFDA. This site is unofficial and independent of the FDA.