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 08/26/2016

Event Type  Injury  

Manufacturer Narrative

Date of birth is unknown as it was not provided.Patient gender is unknown as it was not provided.The laser machine was examined and tested at the customer location by an abbott field service specialist (fss).The fss was not able to reproduce the issue reported.Although, the fss was not able to duplicate the issue, the sesam spot was moved and the amplifier and oscillator output were peaked.The gel was inspected.The field service specialist (fss) performed a checklist and verified all modes of operations.The unit meets amo specifications.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

The surgery center reported during a laser treatment, the surgeon was not able to lift the flap due to the raster pattern not performed and a beam steering error, resulting in an incomplete flap and the procedure was aborted.A brief description from the surgery center indicated the surgeon was able to treat and complete the right eye but when the left eye was treated, complications occurred.The surgeon explained the side cut was performed but the raster pattern was not performed due to the raster pattern was not seen on the monitor.The surgeon attempted to re-treat the left eye to create a raster pattern by re-starting the laser treatment.When re-starting the equipment, a beam steering error appeared.The procedure was aborted and will be converted to a photorefractive keratectomy (prk) treatment at a later date.

• 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: 5965607
• MDR Text Key: 55205044
• Report Number: 3006695864-2016-00845
• 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
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: J20007D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• 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