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 02/14/2017

Event Type  Injury  

Manufacturer Narrative

Application support manager visited account after the event for surgery support and observed surgeon was able to successfully complete lasik cases while there.Laser was found to be within amo clinical tolerances.Field service specialist also visited account and checked laser and no failure was detected.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that system displayed an error message while creating the flap and laser stop firing not making the final edge cut (incomplete flap).Surgeon was unable to lift the flap and procedure was aborted.It was reported that by the site patient is scheduled to return in the near future to complete the surgery.

Manufacturer Narrative

Device evaluation: a review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews for this equipment were performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that 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.It was reported that the probable cause was alignment and calibration.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: 6405076
• MDR Text Key: 69946272
• Report Number: 3006695864-2017-00145
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 20005D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2007
• 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
• Patient Outcome(s): Required Intervention