Recall Z-1007-2023— Johnson & Johnson Surgical Vision, Inc.

Name: FDA recall Z-1007-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-07

Class II · Ongoing

Class II FDA medical device recall by Johnson & Johnson Surgical Vision, Inc., initiated 2022-12-07. It names one FDA 510(k) clearance: K133115. Product: Single-Use Packs, REF: OPO80. Reason: Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema..

Recalling firm: Johnson & Johnson Surgical Vision, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-07
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K133115 — COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACKAbbott Medical Optics, Inc.·cleared 2014-02-27

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

Single-Use Packs, REF: OPO80

Reason for recall

Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

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