Recall Z-0066-2019— Johnson & Johnson Surgical Vision Inc

Name: FDA recall Z-0066-2019
Creator: U.S. Food and Drug Administration
Published: 2018-05-09

Class II · Terminated

Class II FDA medical device recall by Johnson & Johnson Surgical Vision Inc, initiated 2018-05-09, terminated 2021-01-13. It names 5 FDA 510(k) clearances: K172002, K170322, K141079 and 2 more. 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.. 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: Johnson & Johnson Surgical Vision Inc
Classification: Class II
Status: Terminated
Initiated: 2018-05-09
Terminated: 2021-01-13
Firm location: Milpitas, CA, United States

510(k) clearances named in this recall

5 on FDA's record

K172002 — Catalys Precision Laser SystemAmo Manufacturing USA, LLC·cleared 2017-08-25
K170322 — Catalys Precision Laser SystemAbbott Medical Optics, Inc.·cleared 2017-05-19
K141079 — OPTIMEDICA CATALYS PRECISION LASER SYSTEMOptimedica Corporation·cleared 2014-09-11
K121091 — CATALYS PRECISION LASER SYSTEMOptimedica Corporation·cleared 2012-08-28
K113479 — OPTIMEDICA CATALYS PRECISION LASER SYSTEMOptimedica Corporation·cleared 2011-12-21

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

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.

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.

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