MAUDE Adverse Event Report: PRK SURGERY; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cataract (1766); Dry Eye(s) (1814); Retinal Tear (2050); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)

Event Date 07/15/2013

Event Type  Injury  

Event Description

I had prk surgery in 2013.Vision is now a struggle.I have halos and star bursts at night, flashes of light and wiggling flashing lines at times.I got two retina tears on (b)(6) 2014.Dryness is still a problem and been told i will probably have to use artificial drops the rest of my life.After the surgery the doctor told me, he had to overcorrect.My current ophthalmologist said i can see why you struggle with near vision, they certainly did over correct.I had 49 days of multiple drops of antibiotics before/after surgery, too long of regiment considering the risks? was age a factor that should have been taken into consideration especially with the near and mid vision.I was 55.I knew i would have to have reading glasses.Although i need to use very thick ones to read.I gave up my one of my favorite hobbies of reading.I use a magnifying glass sometimes to see smaller things and a 5x mirror to address facial hygiene.My mid-vision is affected and i need glasses to see anything clearly within 10 feet.I have some correction for far distance but been told it cannot be adequately corrected.I was prescribed restasis.My eyes were irritated from the beginning and i thought it was just recovering from the surgery.As an example, at times causing me to pull over and close my eyes for a while when driving.My doctor said it will take a while for the vision to get better and that dryness was interfering.After 20 months on restasis i took myself off.My eyes felt better immediately.The next time i saw my doctor he said whatever you're doing keep doing it, your eyes are not as dry.I told him i took myself off restasis.Then instead of the dryness causing my poor vision he said it was cataracts and there was nothing that could be done.To this day my current ophthalmologist does not have concerns about cataracts.Dr.(b)(6).Fda safety report id# (b)(4).

• Brand Name: PRK SURGERY
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 15067674
• MDR Text Key: 296349197
• Report Number: MW5111005
• 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: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White