MAUDE Adverse Event Report: ALCON LABORATORIES, INC./ WAVELIGHT GmbH LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Blurred Vision (2137); Visual Disturbances (2140)

Event Date 01/30/2019

Event Type  Injury  

Event Description

I had lasik surgery over 10 years ago.After surgery i was completely unable to see.Vision was extremely blurry.I was treated with steroids and regained vision.Night lights were blinding and painful.I also had pain from light during the day.Eventually these symptoms lessened.Lately i have been aware of floaters in both eyes.I am also losing clarity in my vision.My eyesight is becoming blurry again.Another side effect of the surgery is a scar in my right eye.Looks like a brown spot in the blue of my eye, maybe from bleeding during the surgery, not sure.I am going to have my eyes checked out soon by an ophthalmologist to make sure the vitreous humor is not deteriorating to the point of retinal detachment.

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): ALCON LABORATORIES, INC./ WAVELIGHT GmbH
• MDR Report Key: 8297155
• MDR Text Key: 135676690
• Report Number: MW5083632
• Device Sequence Number: 0
• 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: 01/30/2019

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 59