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

Model Number J20007D

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Code Available (3191)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).An amo field service specialist (fss) was informed by the site location, that the event was due to the laser was programmed as side cut only, therefore, the surgery center informed the event was caused by use error.The surgery center indicated the unit is working as intended.All pertinent information available to abbott medical optics has been submitted.

Event Description

The surgery center reported that a laser vision correction patient was provided the incorrect laser treatment, therefore the procedure was not completed and the patient procedure was postpone and the procedure will be converted to a photorefractive keratectomy (prk).A brief description of the event is that left operative eye only received a sidecut during the flap procedure.The right eye was completed without complication.

• 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: 5774397
• MDR Text Key: 48916525
• Report Number: 3006695864-2016-00679
• 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: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: J20007D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2009
• 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
• Patient Age: 47 YR