Recall – Cl II OptiMedica Catalys Precision Laser System

Company: Johnson & Johnson Surgical Vision Inc.
Date of Enforcement Report 10/10/2018
Class lI:

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.

Product #: 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

Recall Number: Z-0066-2019

REASON
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.

RECALLING FIRM/MANUFACTURER
Johnson & Johnson Surgical Vision Inc. Milpitas, CA on 5/9/2018 Voluntary: Firm Initiated

VOLUME OF PRODUCT IN COMMERCE
9

DISTRIBUTION
S Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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