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

Model Number 20003D

Device Problem Contamination (1120)

Patient Problem No Code Available (3191)

Event Date 07/29/2019

Event Type  Injury  

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).All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

It was reported that a laser vision correction patient had surgery on (b)(6) 2019 and presented on (b)(6) 2018 with a 4mm fiber debris under the right eye (od) flap that was discovered at a post treatment.A flap lift and rinse was performed on (b)(6) 2019.It was stated that the patient did not experience a loss of best corrected visual acuity (bcva).The patient reported the symptoms are not interfering with daily activities.Bcva from (b)(6) 2019: right eye pre-op 20/20 -2.50 x -.75 x 165.Left eye pre-op 20/20 -2.75 x -1.25 x 13.

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 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: 8928575
• MDR Text Key: 155507426
• Report Number: 3006695864-2019-00686
• 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
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• 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
• Treatment: WAVELIGHT 1010-3-285; WAVELIGHT (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR