Recall Z-1683-2015— Optimedica Corporation

Name: FDA recall Z-1683-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-20

Class II · Terminated

Class II FDA medical device recall by Optimedica Corporation, initiated 2015-02-20, terminated 2015-12-08. It names one FDA 510(k) clearance: K141079. Product: Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.. Reason: Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters..

Recalling firm: Optimedica Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-02-20
Terminated: 2015-12-08
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K141079 — OPTIMEDICA CATALYS PRECISION LASER SYSTEMOptimedica Corporation·cleared 2014-09-11

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

Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

Reason for recall

Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.

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