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

Model Number 20005D

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The laser machine was examined and tested at the customer location by an abbott field service specialist (fss).When reviewing the error log, the fss confirmed there was a 209- z galvo position check error at 4 seconds remaining to complete the procedure.Although, the error was confirmed in the error log, the fss was not able to duplicate the error.The fss performed 10 test procedures before any service of the system.All test procedures were completed successfully without any errors displayed.No issues were observed during the z scale calibration.The fss proactively replaced the z stepper motor, optimized vertical overlap and pocket overlap flap parameters.After replacement of z stepper motor, the fss performed an additional 25 test procedures without any errors appearing.The field service specialist (fss) performed a checklist and verified all modes of operations.The unit meets amo specifications.All pertinent information available to abbott medical optics has been submitted.

Event Description

The surgery center reported a galvo error displayed.The surgery center attempted to reboot the system but the laser system did not pass the login screen.At the time of the incident there was a patient on the table and the right eye was to be treated.The surgeon made a decision to not lift the flap and rescheduled the patient.There was no consequence to the patient.

Manufacturer Narrative

Correction: manufacturing site reported that the correct manufacturing date for sn (b)(4) is 5/2008 and not 4/30/2008 as provided in the initial report.Additional information: a review of the records related to this equipment shows no failure detected.There is not a 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.Equipment labeling provides potential adverse effects that can be caused by the surgical/treatment procedure being performed.There is no product deficiency identified.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: lourdes guevara ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478497
• MDR Report Key: 5248614
• MDR Text Key: 32088357
• Report Number: 3006695864-2015-00868
• Device Sequence Number: 1
• Product Code: HNO
• 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: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20005D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2008
• 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): Required Intervention