Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0066-2019 · Posted None

Recalling FirmJohnson & Johnson Surgical Vision Inc
Recall StatusTerminated
Product CodeOOE
Date Initiated2018-05-09
Date Terminated2021-01-13
Product Quantity9

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.

Firm 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].

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 2017-08-25K170322Catalys Precision Laser SystemAbbott Medical Optics, Inc. · 2017-05-19K121091CATALYS PRECISION LASER SYSTEMOptimedica Corporation · 2012-08-28K113479OPTIMEDICA CATALYS PRECISION LASER SYSTEMOptimedica Corporation · 2011-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑