MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. INTRALASE FS3; FEMTOSECOND LASER

Model Number 20004

Device Problems Energy Output Problem (1431); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing date requested but not available at the time of this report.(b)(4).System was checked after the event.The system was checked and an electrical problem was found.Parts were replaced ans system was left within specifications.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.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

It was reported that during the last 3 seconds of a procedure the system stopped for a second time and surgeon was unable to lift the flap as the flap was not completed.This occurred in the patients left operative eye.The right eye was done without complications prior to the event.The procedure was not completed that day.

Manufacturer Narrative

Additional information: h4 - manufacturing date - the manufacturing site reported that the manufacturing date for the device is 10/27/2005.H3 other text : placeholder.

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 nr-0148919 and capa-010215.

• Brand Name: INTRALASE FS3
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9455708
• MDR Text Key: 183515815
• Report Number: 3006695864-2019-00976
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Public: (01)
• Combination Product (y/n): Y
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20004
• Device Catalogue Number: 20004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1