MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS INTRALASE FS3; FEMTOSECOND LASER

Model Number 20004

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Keratitis (1944)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Field service specialist visited the account.Prior to fse's arrival, customer reported seeing a ''fan error'' upon start-up.System checkout was performed.Found ac/dc switcher fan defective.Replaced ac/dc switcher as required.Fse on site observed ''galvos buzzing.'' ordered replacement galvo assembly, and installed as required.Successfully completed 3 month preventive maintenance verifications.System meets abbott specifications.All pertinent information available to abbott medical optics has been submitted.

Event Description

Surgeon reported that patient presented with diffuse lamellar keratitis (dlk) grade 1 trace 24hrs post treatment in both eyes.Surgeon gave treatment with maxidex in both eyes every 2 hours.Best corrected visual acuity (bcva) in both eyes is 20/20.

• Brand Name: INTRALASE FS3
• 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: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 5766941
• MDR Text Key: 48712246
• Report Number: 3006695864-2016-00657
• Device Sequence Number: 1
• Product Code: HNO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2006
• 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: 33 YR