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

Model Number 20005J

Device Problems Decrease in Suction (1146); Device Operates Differently Than Expected (2913)

Patient Problem Visual Impairment (2138)

Event Date 05/06/2016

Event Type  Injury  

Manufacturer Narrative

Udi #: (b)(4).Initial reporter phone number (b)(6).Application support manager (asm) reviewed a video provided by the account of the event.He was able to observe lack of suction (prior to laser being fired) and was able to confirmed what was reported.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that side cut issue was observed during surgery on (b)(6) 2016.Doctor noticed side cut was incomplete because it was difficult to turn up the flap of right eye: the flap bed was cut completely.They reported that a review of the video showed the pocket positioned between 5 o'clock and 7 o'clock and between 6 o'clock and 9 o'clock there was not cut.Nurse thought flap had a wrinkle when doctor cut the incomplete part using an instrument for holding the flap.Operation (including excimer laser ablation) was successfully completed on the day applying a bandage contact lens.The issue was observed in the first surgery today.There was no problem observed with the next surgery.

• Brand Name: INTRALASE
• 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: 5699731
• MDR Text Key: 46561756
• Report Number: 3006695864-2016-00583
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20005J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2008
• 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): Other
• Patient Age: 30 YR