MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS INTRALASE FS2; FEMTOSECOND LASER

Model Number 20003

Device Problem Energy Output Problem (1431)

Patient Problem Keratitis (1944)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clinic is reporting this adverse event only and did not request or require field service or clinical support.Equipment labeling provides potential adverse effects that can be caused by the surgical/treatment procedure being performed.The operator manuals for the various equipment were reviewed and determined to include adequate warnings for medical complications.All pertinent information available to abbott medical optics has been submitted.

Event Description

The surgery center reported that a laser vision correction patient was presented with a bilateral diffuse lamellar keratitis (dlk) at 1 day post-operative exam.Topical steroids and oral prednisone were used to treat the dlk.The surgeon is planning on decreasing the bed energy.The patient's uncorrected visual acuity for both eyes are 20/15.

• Brand Name: INTRALASE FS2
• 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: 4998418
• MDR Text Key: 22804079
• Report Number: 3006695864-2015-00502
• 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
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2004
• 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): Other