{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "166720", "product_res_number": "Z-0066-2019", "event_date_initiated": "2018-05-09", "event_date_created": "2018-10-03", "recall_status": "Terminated", "event_date_terminated": "2021-01-13", "res_event_number": "80849", "product_code": "OOE", "k_numbers": [ "K113479", "K121091", "K141079", "K170322", "K172002" ], "product_description": "OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33\n\nProduct Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states \"Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA\n\nProduct Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states \"Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA\n\n 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.", "code_info": "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", "firm_fei_number": "3006695864", "recalling_firm": "Johnson & Johnson Surgical Vision Inc", "address_1": "510 Cottonwood Dr", "city": "Milpitas", "state": "CA", "postal_code": "95035-7403", "additional_info_contact": "Carlos Reyes\n408-273-4275", "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_description": "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 RegComplione@its.jnj.com, 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.\n\nIf you have any questions, contact the Director, Quality Assurance at 408-273-4100 or email: creyes51@its.jnj.com.", "product_quantity": "9", "distribution_pattern": "US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.", "openfda": { "k_number": [ "K173660", "K141476", "K123859", "K181430", "K110427", "K090633", "K243896", "K121091", "K170322", "K122386", "K141379", "K092647", "K213559", "K170576", "K171337", "K141079", "K140615", "K151161", "K082947", "K120426", "K101626", "K223566", "K094052", "K152453", "K220516", "K182795", "K252682", "K220259", "K113479", "K143010", "K173346", "K223838", "K120214", "K200056", "K102727", "K161455", "K123120", "K172002", "K163551", "K112098", "K150323", "K182083", "K132534", "K200724", "K161288", "K171014", "K210701" ], "registration_number": [ "3010208880", "1650907", "1450662", "1424263", "3005012805", "1928237", "3009026057", "3005675890", "2244478", "3006946276", "3005173255", "1721676", "3003537036", "3003288808", "3009420598", "3010160527", "2028159", "3007606649", "1649518", "3006695864", "9710340", "2134604", "3004858034", "3009298127", "3023808060", "3012236936", "1920664", "1644019", "3010291427" ], "fei_number": [ "3010208880", "1450662", "3005012805", "3003015552", "1928237", "3009026057", "3005675890", "3002681132", "1000136269", "3006946276", "3002807040", "3005173255", "1721676", "3003537036", "3003288808", "3002623849", "3009420598", "3006695864", "3004858034", "3009298127", "3023808060", "3002483854", "3012236936", "3003691824", "1000125771", "1000117501", "1920664", "3001236277", "3010291427" ], "device_name": "Ophthalmic Femtosecond Laser", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4390", "device_class": "2" } } ] }