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U.S. Department of Health and Human Services

Class 2 Device Recall OptiMedca Catalys Precision Laser System

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  Class 2 Device Recall OptiMedca Catalys Precision Laser System see related information
Date Initiated by Firm May 09, 2018
Create Date October 03, 2018
Recall Status1 Terminated 3 on January 13, 2021
Recall Number Z-0066-2019
Recall Event ID 80849
510(K)Number K113479  K121091  K141079  K170322  K172002  
Product Classification Ophthalmic femtosecond laser - Product Code OOE
Product OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33

Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA

Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA

The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Code Information Model: Catalys Precision Laser System, CE 0044:  Catalys-U (US version) Serial Numbers: 44065613 - software cOS 5.00.33 install date 4/27/2018 46131618 - software cOS 5.00.33 install date 4/23/2018 46131418 - software cOS 5.00.33 install date 4/30/2018 44107315 - software cOS 5.00.33 install date 5/1/2018 46120916 - software cOS 5.00.33 install date 4/23/2018 46123116 - software cOS 5.00.33 install date 5/2/2018 44106215 - software cOS 5.00.33 install date 5/3/2018  Catalys-I (International version) Serial Number: 44109015 - software cOS 5.00.33 install date 5/1/2018 46124617 - software cOS 5.00.33 install date 5/3/2018
Recalling Firm/
Manufacturer		 Johnson & Johnson Surgical Vision Inc
510 Cottonwood Dr
Milpitas CA 95035-7403
For Additional Information Contact Carlos Reyes
408-273-4275
Manufacturer Reason
for Recall		 Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.
FDA Determined
Cause 2		 Device Design
Action On May 9, 2018, affected customers in the U.S. and Puerto Rico were contacted by phone and verbally informed to stop using the affected system. On May 22, 2018, the firm, Johnson & Johnson Vision, sent an "URGENT MEDICAL DEVICE FIELD REMOVAL" letter dated May 18, 2018 via Federal Express overnight delivery with signature required to all customers with a system containing the affected software installed. The customers were instructed to: STOP Using the affected system and complete and return the Customer Reply Form via fax to: Johnson & Johnson Vision Quality Assurance at 1-714-247-4510, emailed to RegComplione@its.jnj.com, or provide to your Johnson & Johnson Vision Representative within 3 business days of receipt of the letter. The firm will coordinate the removal of the affected software for all affected systems. All impacted customers will be provided with the new/updated software version. If you have any questions, contact the Director, Quality Assurance at 408-273-4100 or email: creyes51@its.jnj.com.
Quantity in Commerce 9
Distribution US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OOE and Original Applicant = Abbott Medical Optics Inc.
510(K)s with Product Code = OOE and Original Applicant = AMO Manufacturing USA, LLC
510(K)s with Product Code = OOE and Original Applicant = OPTIMEDICA CORPORATION
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