MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS SYSTEM

Model Number	0160-6020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).Equipment labeling has precautions regarding the following: "the catalys® system has not been adequately evaluated in patients with a cataract greater than grade 4; therefore no conclusions regarding either the safety or effectiveness are presently available." all pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
Surgeon reported that zonular dehiscence was identified halfway through the phaco portion of the procedure.Nuclear lens material migrated to the posterior chamber.The procedure was completed without intra ocular lens (iol) implantation.The surgeon stated that the patient had a dense brunescent cataract.The surgeon also reported that the outcome was related to the patient¿s anatomy and was not a complication due to the catalys treatment.The patient was referred for retinal consultation for retained lens nucleus.
Additional Manufacturer Narrative
Correction: in initial report, device manufacture date was provided as 08/08/2018, however, the device manufacture date is 03-aug-2018 (08/03/2018).This follow-up report has the correct date in device manufacture date.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: CATALYS SYSTEM
• Common Device Name: CATALYS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8974355
• Report Number: 3005675890-2019-00075
• Device Sequence Number: 335452
• Product Code: OOE
• UDI-Device Identifier: 05050474617186
• UDI-Public: (01)05050474617186
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K121091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0160-6020
• Device Catalogue Number: 0160-6020
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 11/05/2019; 10/25/2020
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 11/27/2019; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005