MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS INTRALASE; PATIENT INTERFACE

Model Number PI-RET

Device Problems Suction Problem (2170); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The patient interface (pi) suction ring may lose suction during a procedure.Label copy states corneal fixation vacuum loss can occur.There are several factors that may contribute to suction issues such as doctor¿s technique in applying the suction ring to the cornea, doctor¿s technique in squeezing the pi clip to secure the suction ring to the pi cone and patient anatomy affecting the interface between the patient¿s cornea and the suction ring.All pertinent information available to abbott medical optics has been submitted.

Event Description

The account reported galvo error and suction loss during surgery with an intralase patient interface (pi) after the patient was applanated and after the laser fired.It is also noted that the procedure was completed successfully.There was a flap/ring replaced.There was no patient injury reported and no surgical intervention was required.

• Brand Name: INTRALASE
• Type of Device: PATIENT INTERFACE
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 5579140
• MDR Text Key: 42766078
• Report Number: 2648035-2016-00594
• 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: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/08/2017
• Device Model Number: PI-RET
• Device Lot Number: CA14718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1