MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS / AMO MANUFACTURING USA, LLC VISX STAR 4; EXCIMER LASER SYSTEM

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2018

Event Type  Injury  

Event Description

I underwent lasik surgery on both my right and left eyes.The laser performed correctly on my right eye and i now have better than 20/20 vision.When dr (b)(6) attempted correction of my left eye, she was unable to "lift the flap" and after 20 mins of trying aborted the procedure.The following day when i went back for re-evaluation, i was informed "the laser malfunctioned".I have since had improvement of my left eye sight.I wish to lodge a report on the laser used by dr (b)(6).The laser used the visx star 4.The laser is reportedly serviced regularly.When a tech from the company evaluated the laser the following day, it was not correctly collaborated.

• Brand Name: VISX STAR 4
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS / AMO MANUFACTURING USA, LLC
• MDR Report Key: 7757452
• MDR Text Key: 116555066
• Report Number: MW5078907
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Weight: 84