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

Model Number J20007D

Device Problem Energy Output Problem (1431)

Patient Problem No Code Available (3191)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Field service specialist (fss) visited the account and checked laser and confirmed max energy too low error.Fss found amp current driver faulty, replaced amp glass to bring energy levels to spec and issue resolved.System meets all jnj 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 the surgeon experienced an incomplete flap during flap creation due to low energy on laser.He explained it stopped a few seconds before treatment was completed and confirmed that no side-cut was created.He also explained that the bubbles looked abnormal as if it wasn't actually doing any resection plane.Surgeon will attempt to create flap again at future date and time.Clinical discussed using new cone and going 40 microns deeper than originally programmed.

Manufacturer Narrative

Correction: in initial report, the device manufacture date was inadvertently reported as 11/30/2011, however the correct date is 12/15/2011.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

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: 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: 9531570
• MDR Text Key: 173075221
• Report Number: 3006695864-2019-01020
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474573468
• UDI-Public: (01)05050474573468
• 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: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: J20007D
• Device Catalogue Number: J20007D
• 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