MAUDE Adverse Event Report: AMO VISX S4 LASER

Device Problem Insufficient Information (3190)

Patient Problems Endophthalmitis (1835); Keratitis (1944); Retinal Detachment (2047); Visual Impairment (2138); Impaired Healing (2378); Fungal Infection (2419)

Event Date 12/06/2013

Event Type  Injury  

Event Description

I do not know the type of bandaid contact lenses used and it is not recorded in my chart.Amo is maker of the of the visx laser, maker of contact lens unknown.The pt had prk surgery on (b)(6) 2013 at (b)(6).She previously had lasik in 2000 and was seeking treatment for regression.Her prk surgery was on the visx s4 laser.Bandaid contact lenses were placed in her eyes at the end of the prk surgeries.She was seen on post op day one and her next appointment was (b)(6) 2013.She returned for her appointment on (b)(6) 2013, for removal of the bandaid contact lenses.At that time her epithelium had not healed, and she had asymmetric healing.No doctor (ophthalmologist or optometrist) was in the office when she returned for her appointment for removal of the bandaid contact lens, and the laser technician removed and replaced the bandaid contact and advised her to continue steroid drops 4 times a day and return in 5 days.Four days later on (b)(6) 2013, she went to the emergency room, and the next day to a corneal specialist.She was diagnosed with fungal keratitis and fungal endophthalmitis.She has had aggressive treatment since that time with multiple oral and topical medications and injections to her eye, but has lost her eye.She has no light perception, and a retinal detachment.She is scheduled for surgery for a corneal transplant, iol implant and repair of retinal detachment.She will likely lose her eyeball.

• Brand Name: VISX S4 LASER
• Type of Device: LASER
• Manufacturer (Section D): AMO
• MDR Report Key: 3610325
• MDR Text Key: 4064874
• Report Number: MW5034192
• Device Sequence Number: 1
• Product Code: GEX
• 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: 01/31/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2014
• Patient Sequence Number: 1
• Treatment: PAIN MEDICATIONS FOR HEADACHE
• Patient Outcome(s): Other; Disability
• Patient Age: 34 YR
• Patient Weight: 61