MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. INTRALASE FS2; FEMTOSECOND LASER

Model Number 20003D

Device Problem Energy Output Problem (1431)

Patient Problem No Code Available (3191)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing date of device: requested but not available at the time of this report.(b)(4).The field service specialist (fss) visited the account and upon arrival was able to confirm the issue.The system was sent to the manufacturing site as an incomplete repair and a new system was installed.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 a laser vision correction surgery and while the flap was being created the system presented with max energy low message.They converted the patient to photorefractive keratectomy.The patients first eye was completed without incidents and the event occurred in the second eye.

Manufacturer Narrative

Correction: h4 - manufacturing date - the manufacturing site reported that the manufacturing date for the device is 03/07/2007.

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: INTRALASE FS2
• 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: 9412721
• MDR Text Key: 169135496
• Report Number: 3006695864-2019-00940
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20003D
• 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
• Patient Outcome(s): Required Intervention