MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS INTRALASE FS3; FEMTOSECOND LASER

Model Number 20004

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Field service specialist visited the account to check the system.System completed 20 minute warm-up without error.All signals look good on scope.Performed checks and restarted system with no errors.Second day of system check fss did adjustments and complete 3 month pm without any errors.All pertinent information available to abbott medical optics has been submitted.

Event Description

Account reported intermittent energy errors on last surgery day.The account contact could not recall if the errors occurred during laser firing or not but patient was rescheduled and procedure was not completed on the same day.

• Brand Name: INTRALASE FS3
• 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: 5855467
• MDR Text Key: 51442855
• Report Number: 3006695864-2016-00770
• 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: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2005
• 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