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

Model Number J20007D

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/04/2018

Event Type  Injury  

Manufacturer Narrative

Field service specialist visited account and confirmed issue.Parts were replaced and system was left ready for use.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 surgeon completed patient¿s intralase flap procedure in right eye without issue.When treating left eye there was a 106 main shutter error message that forced surgeon to re-dock and applanate the eye.Lost suction during raster pattern os and when attempting to re-dock and applanate another error message (galvo error) displayed not allowing completion of procedure.Surgeon aborted intralase completion.Patient returned on (b)(6) 2018 and flap was created successfully and excimer treatment was completed.Patient¿s post op best corrected visual acuity is 20/20 in left eye.This case is for the event of the intralase treatment interrupted and that was not able to be completed on the same day.A separate report is being submitted for the event of suction loss while laser is firing.

Manufacturer Narrative

A review of the records related to this equipment that included labeling, manuals, trending, and risk documentation reviews for this equipment were performed.The trend review shows that there is not significant change over historical complaint limits and no recognizable adverse trend.The risks and mitigation associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.Based on the investigation an electrical and mechanical problem was found.There was no product deficiency identified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: IFS
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7545966
• MDR Text Key: 109304923
• Report Number: 3006695864-2018-01220
• 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
• Report Date: 01/01/2005,07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: J20007D
• Device Catalogue Number: J20007D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR