Z-0066-2019Class II

OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial...

Name: Z-0066-2019 OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial...
Creator: Johnson & Johnson Surgical Vision Inc
Published: 2018-05-09
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2018-05-09 / Terminated / root cause: design

FDA source

Johnson & Johnson Surgical Vision Inc began a recall of OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613... on 2018-05-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0066-2019
Classification: Class II
Status: Terminated
Initiated: 2018-05-09
Posted: 2018-10-03
Terminated: 2021-01-13
Recalling firm: Advanced Medical Optics, Inc.
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 code: OOE Ophthalmic Femtosecond Laser
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.
Root cause tag: design
FDA root cause: 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 [email protected], 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: [email protected].
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0066-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0066-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03

Product code OOE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)