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

Model Number 20005D

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer refused service of system at this time.(b)(4) reported that the laser was programmed to 110 depth.Surgeon stated no noticable scarring or abnormalities in the patients cornea.(b)(4) checked cone it read -22/7 tilt.Laser also gave 301 gantry error 2 times.He said it is intermittent and able to recover.After last case of the day the laser also gave an oscillator mode lock error but recovered.All pertinent information available to abbott medical optics has been submitted.

Event Description

Surgeon reported small vertical gas breakthrough on the patient's right eye.The surgeon decided to abort and bring patient back to cut another flap at least 40 microns deeper once vision is stable.Surgeon wiped epithelial surface with an instrument and created epithelial defect.Surgeon placed bandage contact lens.It was also reported laser gave 301 gantry error 2 times.

• 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: 5746561
• MDR Text Key: 48093591
• Report Number: 3006695864-2016-00641
• 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: Physician
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20005D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2008
• 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