MAUDE Adverse Event Report: ALCON LASER TECHNOLOGY / WAVELIGHT GMBH (PRESSATH) THE WAVELIGHT EX500; EXCIMER LASER SYSTEM

Model Number 8065990794

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Eye Injury (1845); Laceration(s) (1946); Blurred Vision (2137); Eye Pain (4467)

Event Date 09/26/2014

Event Type  Injury  

Event Description

Simple really.During the procedure at the (b)(6), the surgeon had done.My right eye and everything was going fine and about 4 to 5 seconds into my left eye, and i felt a sharp stabbing burning pain that actually caused me to jump and howl in pain, almost ripped my head out of the surgical device.The very moment right before i screamed out the surgeon quietly says "oh.Shoot." as he's saying it, i yank my head back in response to a very unexpected excruciating jolt of pain in my left eye.It felt like a searing laceration to the side of my eyeball.The surgeon quickly says "sorry sorry sorry omg, it's ok you're fine , just a nick.Very common.He finished the procedure and out the drops in and my eye kept burning pain.But a few days later then my eyes were pretty much healed from the surgery.I didn't see any visible marks or redness, besides a little bit of bloodshot from the dryness.My left eye didn't bother me as much as it had been and seemed to be healing really well as my right, only my left peripheral was really blurry.But i was told to give the surgery a few weeks to fully heal.So i figured nothing went wrong but, oh how wrong i would come out i was.A few weeks after i still had blurry peripheral in my left eye.I called the institute and was told give it more time.I eventually just figured it's like how's plastic surgery or cosmetic surgery that even though you might heal in three or four months, it's actually a year before, you sleep over results, little did i know that they had a year policy about if your eye vision changes, they only give you a year, so when i called back again after they told me to wait.They had already said my year was up so i guess they took no responsibility for it, still can't see out of my left eye peripheral.But actually just a few years into after getting the surgery i noticed my actual eyesight declining worse than it was 'cuz' i had a correction of astigmatism but i actually had now worst vision whereas before i would just have problems with seeing halos and things like that trouble driving at night where now i can't read small print, so yes your eyes do get worse with age but you know this is only a couple years since the surgery, so it's terrible.I wish i never got it.I spent so much money, i was in debt and i thought it was supposed to fix my eyes but it actually ended up making them worse.I noticed every year my eyesight declining and i now need a magnifier to read small print.I mean i'm still way too young for that to be happening.I regretted it every day of my life.Custom wavefront optimized lasik surgery laser vision correction procedure evaluation exam and vision test.Fda safety report id# (b)(4).

• Brand Name: THE WAVELIGHT EX500
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): ALCON LASER TECHNOLOGY / WAVELIGHT GMBH (PRESSATH)
• MDR Report Key: 13002012
• MDR Text Key: 282358243
• Report Number: MW5106012
• Device Sequence Number: 1
• Product Code: LZS
• UDI-Device Identifier: 00380659907944
• UDI-Public: 00380659907944
• 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: 12/09/2021

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
• Device Model Number: 8065990794
• Device Catalogue Number: 8065990794
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2021
• Patient Sequence Number: 1
• Treatment: EYE TREATMENT FOR IRRITATION; LUBRICATING GEL EYE DROPS ; MULTI VITAMIN ; OMEGA-3 FATTY ACIDS ; PREVACID ; VITAMIN A
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White