MAUDE Adverse Event Report: CUSTOM VUE LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cataract (1766); Dry Eye(s) (1814); Glaucoma (1875); Loss of Vision (2139); Halo (2227); Depression (2361)

Event Date 01/27/2004

Event Type  Injury  

Event Description

Custom vue lasik performed on both eyes on (b)(6) 2004.Followed by custom vue lasik enhancement to left eye on (b)(6) 2009.Custom vue lasik procedures dr (b)(6) eye care of (b)(6).Lasik both eye-(b)(6) 2004, lasik enhancement left eye (b)(6) 2009; (b)(6)2011 - post lasik ectasia, told i needed cornea collagen cross linking.Ongoing medical to treat damage caused by lasik.On (b)(6) 2011 confirmed post lasik ectasia diagnosis went on waiting list for clinical trials of cornea collagen cross linking (b)(6) medical.On (b)(6) 2012 cxl performed on both eyes at (b)(6).On (b)(6) 2012 dalk cornea transplant left eye (b)(6).On (b)(6) 2017 (b)(6) jhu glaucoma specialist - began treatment for suspect glaucoma left eye, also cataracts in both eyes with the left eye more advanced.Permanent damage to quality of vision.I will list some of the debilitating conditions that i deal with every day.I was told by refractive specialist that i will no longer see in real life high definition, clear crisp lines.Driving - only drive locally under clear conditions, night driving is near impossible due to intense glare, halos and star bursts of oncoming headlights.Chronic dry eye see medication / over counter section.Contrast sensitivity best case for me now is an object in 2d black image on a white background anything else will be various levels of difficulty.For example grocery shopping think of all the sizes, shapes, and colors of packaging.Depth perception trouble with step, ladders, change in elevations walking, i have sliced myself with a kitchen knife so many times i have lost count.Peripheral vision, field of view has decreased by approx 40 degrees on both sides.Depression, etc.

• Brand Name: CUSTOM VUE LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 7893221
• MDR Text Key: 121442080
• Report Number: MW5079923
• 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: 09/18/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 57 YR