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

Model Number J20007D

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The laser machine was examined and tested by an abbott field service specialist (fss).The fss was not able to reproduce the z galvo error that was reported, however the error was confirmed when reviewing the error logs.The fss replaced delivery system interface pcb and encoder to address intermittent occurence of z galvo out of position errors.The fss verified system performance after 4 hours of cold start; z encoder counts were stable on a cold start as well.The fss performed 10 burn-in test procedures; all procedures completed without any errors.The fss performed a field service checklist.The system was verified for all modes of operations and calibrations.The system met amo specifications.All pertinent information available to abbott medical optics has been submitted.

Event Description

The surgery center reported that a laser vision correction patient experienced an incomplete flap on the operative eyes resulting in aborting the procedure.A description from the surgery center indicated the laser equipment displayed a z-galvo error and it was resolved by rebooting the equipment.After the reboot, the surgeon was able to perform half of the procedures scheduled for the day, when in one of the procedures, the flap creation had started cutting near the center of the operative eye.The surgeon indicated when the cutting was at the near center of the eye, it was like a suction break occurred but the surgeon could tell there was good contact.The surgeon disabled the foot switch and aborted the procedure.The rest of the procedures scheduled for the day were cancelled.

Manufacturer Narrative

A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the 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: IFS
• 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: lourdes guevara ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478497
• MDR Report Key: 7102664
• MDR Text Key: 94353894
• Report Number: 3006695864-2017-01298
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474573468
• UDI-Public: (01)05050474573468
• 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,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: J20007D
• Device Catalogue Number: J20007D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2012
• 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