Recall Z-1964-2016— Staar Surgical Co.

Name: FDA recall Z-1964-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-02

Class II · Terminated

Class II FDA medical device recall by Staar Surgical Co., initiated 2016-05-02, terminated 2016-11-15. It names one FDA 510(k) clearance: K940593. Product: STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.. Reason: The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses)..

Recalling firm: Staar Surgical Co.
Classification: Class II
Status: Terminated
Initiated: 2016-05-02
Terminated: 2016-11-15
Firm location: Monrovia, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K940593 — DISPOSABLE MICROSTAAR INJECTORStaar Sugical·cleared 1994-09-19

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

STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.

Reason for recall

The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).

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