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

Model Number J20007J

Device Problem Energy Output Problem (1431)

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

Event Date 11/09/2019

Event Type  malfunction  

Manufacturer Narrative

Phone number: (b)(6).Manufacturing date requested but not available at the time of this request.Field service specialist (fss) visited the account and was not able to confirm the reported issue.He preventively replaced power supply ac/dc (alternate/direct current) switcher and assembly power supply.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

Account reported error message occurred when creating the pocket area of the intralase flap.

Manufacturer Narrative

H4: additional: the device manufacturer date was provided as 06/03/2008.H4 of this follow up has been updated.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.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: IFS
• 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: 9447792
• MDR Text Key: 183516296
• Report Number: 3006695864-2019-00965
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474547698
• UDI-Public: (01)05050474547698
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: J20007J
• Device Catalogue Number: J20007J
• Was Device Available for Evaluation?: Yes
• 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