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

Model Number 20005D

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

Field service specialist visited the account and was unable to reproduce the beam steering error.He peaked power and preformed preventive maintenance and the unit passed all abbott specifications.All pertinent information available to abbott medical optics has been submitted.

Event Description

Account reported that system stopped during patient treatment with error message and were not able to complete the procedure that same day.Patient was re-scheduled.

• 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: 6291906
• MDR Text Key: 66214875
• Report Number: 3006695864-2017-00059
• 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: Other
• Type of Report: Initial
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 20005D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2009
• 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