MAUDE Adverse Event Report: LASIK MACHINE; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Emotional Changes (1831); Eye Injury (1845); Vitreous Floaters (1866); Inflammation (1932); Visual Impairment (2138); Anxiety (2328); Depression (2361)

Event Date 05/06/2021

Event Type  Injury  

Event Description

Lasik complications; i got lasik and i am almost 7 months post op and i have had severe dry eye and inflammation everyday.Nothing is helping my eyes return to normal and because of this i had to quit my job because certain air conditioning causes my eyes to be very irritated.I have tried autologous serum tears, regener-eyes, punctual plugs, ipl, several artificial tears, warm compresses, cold compresses, and because of this i am depressed and anxious and stay home a lot.I have lost the quality of my life because my eyes are driving me crazy constantly.I am so scared that lasik has done permanent damage to my eyes.I also now have a big floater in one eye and i also now have an astigmatism, which i did not have before lasik.I was told that the lasik exacerbated meibomian gland disorder that i apparently had before lasik, but had no issues with until after lasik.My surgeon should have checked my whole eyes to see if they were healthy enough instead of just checking the corneal thickness.They said that since i wore contacts for year that my eyes will be fine.Clearly that is not the case.Fda safety report id # (b)(4).

• Brand Name: LASIK MACHINE
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12916996
• MDR Text Key: 281685691
• Report Number: MW5105733
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/29/2021

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female