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

Model Number 20005K

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Field service specialist visited the account after the event and found that z galvo position check error is cleared by encoder alignment followed by z scale and baseline offset calibrations.Several burn-in tests were performed and no errors were observed.Device was within specifications.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during a ring treatment system had a z galvo position check error in the last 3 seconds.Treatment can not be finished that day and patient returned next day to complete procedure.The believes it was caused by the intralase.

Manufacturer Narrative

Device evaluation: a review of the records related to this equipment shows a mechanical failure.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.There is not a recognizable adverse trend based on the trend review and risk evaluation.Equipment labeling provides potential adverse effects that can be caused by the surgical/treatment procedure being performed.The operator manuals for the equipment were reviewed and determined to include adequate warnings and precautions for medical complications.There was 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: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 5388522
• MDR Text Key: 36759364
• Report Number: 3006695864-2016-00086
• Device Sequence Number: 1
• Product Code: HNO
• Combination Product (y/n): N
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 20005K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2012
• 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