MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS STAR; VISX EXCIMER

Model Number 0030-1479

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: femto laser, sn unknown; patient interface, lot number: unknown.The field service specialist (fss) visited customer site to inspect the unit.Fss could not adjust the joystick.Fss replaced the joystick and verified proper operation of the device.The laser was found operating within specifications.Device manufacture date: unknown.All pertinent information available to the manufacturer has been submitted.

Event Description

The customer reported unintended chair movement (chair creeping) toward the right eye (od) from the chair attached to excimer laser/visx system and as a result a suction break while laser was operating occurred.The account reported that they verified the chair movement by watching the chair over a period of time and that it moved.There was no patient treatments delayed or cancelled.This mdr report pertains to bed creeping event on the excimer laser system.A separate mdr report will be submitted for the suction loss event with the intralase patient interface.

Manufacturer Narrative

The labeling, trending and risk documentation reviews for this equipment were performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the received complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: STAR
• Type of Device: VISX EXCIMER
• 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: 7069673
• MDR Text Key: 93735236
• Report Number: 3006695864-2017-01219
• Device Sequence Number: 1
• Product Code: LZS
• UDI-Device Identifier: 00(01)(21)3058
• UDI-Public: (01)(21)3058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 0030-1479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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