MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS INTRALASE FS2; FEMTOSECOND LASER

Model Number 20005D

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Field service specialist was unable to duplicate/reproduce error message.Perform encoder check and fine adjustment.Laser is ready for treatment all pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that after the raster pattern of the flap procedure in the right eye was completed a 209 error code message presented prior to the side cut.The laser could not be cycled and the procedure was aborted.Surgeon confirmed that a new flap using a depth (b)(6) microns away from the original programmed flap depth was successfully created on (b)(6) 2017.There was no report of loss of best corrected visual acuity (bcva) and no patient injury.

Manufacturer Narrative

A review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed.The trend review shows that there is no significant change over historical complaint limits and no recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: INTRALASE FS2
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 6978916
• MDR Text Key: 90286667
• Report Number: 3006695864-2017-00967
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474573451
• UDI-Public: (01)05050474573451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 20005D
• Device Catalogue Number: 20005D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other