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 05/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Field service specialist (fss) visited the account and check the laser after the event.Fss reported errors were seen in the error log file.Monitored 24vdc (volts direct current) and observed that it was dropping energy from 23.96 to 23.52 after 1 hr.Replaced ac/dc switcher power supply.All pertinent information available to abbott medical optics has been submitted.

Event Description

Account reported that system gave error message of beam steering and pocket high voltage error prior to procedure.System was rebooted and the errors cleared.One patient flap was not lifted after creation.The next one (flap) was ok.During follow up it was found that patient is scheduled to have secondary lasik procedure with microkeratome at the end of (b)(6) 2016.

• 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 sedz ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 5743903
• MDR Text Key: 47993833
• Report Number: 3006695864-2016-00639
• Device Sequence Number: 1
• Product Code: HNO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2005
• 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