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

Model Number CATALYS-I

Device Problem Mechanical Problem (1384)

Patient Problems Corneal Edema (1791); Vitrectomy (2643)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Reporter phone: (b)(6).Investigation results the catalys laser cataract system machine was examined and tested at the customer location by a jjsv field service engineer (fse).The fse added filter to door's ventilation, added grease to chair's lock which is related to docking issues.Reinstalled gui to avoid menu errors to resolve the issue.The fse performed a field service checklist.The system was verified for all modes of operations.The system met jjsv specifications.A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for the catalys laser system showed that there were no issues or non-conformities.The system and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Based on the investigation results there is no indication of a product quality deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaint.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

Customer reported that they had docking problems causing a corneal edema on a patient during surgery with the catalys-i system.Corticosteroids were prescribed in addition to the regular post-op cataract medication and a vitrectomy was performed as a secondary intervention.The liquid optics interface (loi) was replaced and surgery was completed successfully.The patient is being monitored.No further information available.

• Brand Name: CATALYS SYSTEM
• Type of Device: CATALYS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10752416
• MDR Text Key: 213660730
• Report Number: 3005675890-2020-00055
• Device Sequence Number: 1
• Product Code: OOE
• UDI-Public: (01)
• Combination Product (y/n): Y
• Reporter Country Code: ES
• PMA/PMN Number: K121091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CATALYS-I
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LIQUID OPTICS INTERFACE, LOT 13998715
• Patient Outcome(s): Required Intervention