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

Model Number 20003D

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The laser machine was examined and tested at the customer location by an abbott field service specialist (fss).The fss was able to confirm the 523 beam steering errors by reviewing the error logs but was not able to duplicate when testing of the system.The fss replaced and tuned the amplifier.The fss performed a preventative maintenance, aligned and calibrated the laser system.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 during a laser treatment, error 523- beam steering incomplete message appeared.A brief description from the surgery center indicated the error is intermittent with no warning message.The error presents itself after the cone is docked on the eye.When the error occurs, the surgeon released the suction on the patient in order for the error to clear.The surgeon re-applied the suction and the flap was created successfully.The surgery center is concerned due to the consistency and intermittent error that occurs after suction is applied.Out of 16 procedures scheduled for the day, the error occurred three times at various lengths of time.Although, the error appeared several times, there was one procedure that was not completed resulting in an aborted procedure.The surgeon was able to complete the right eye but the error appeared once again and the error message would not clear.The surgery center was not able to continue the procedure.The patient's left eye's laser treatment and remaining scheduled treatments were cancelled and rescheduled.There is no patient injury reported.

• 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: 5313060
• MDR Text Key: 33935877
• Report Number: 3006695864-2015-00949
• 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: Other
• Type of Report: Initial
• Report Date: 12/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20003D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2007
• 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
• Treatment: PATIENT INTERFACE