ClearanceBrief
Recall Z-0066-2019 ยท OOE Ophthalmic Femtosecond Laser

Johnson & Johnson Surgical Vision Inc

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 Cor

DateMay 9, 2018
StatusTerminated
ReasonSoftware 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 causeDevice Design
ActionOn 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, ema
Quantity9
DistributionUS Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K113479OPTIMEDICA CATALYS PRECISION LASER SYSTEM
Optimedica Corporation, Dec 21, 2011
K121091CATALYS PRECISION LASER SYSTEM
Optimedica Corporation, Aug 28, 2012
K141079OPTIMEDICA CATALYS PRECISION LASER SYSTEM
Optimedica Corporation, Sep 11, 2014
K170322Catalys Precision Laser System
Abbott Medical Optics, Inc., May 19, 2017
K172002Catalys Precision Laser System
Amo Manufacturing USA, LLC, Aug 25, 2017