MAUDE Adverse Event Report: UNKNOWN LASIK; EXCIMER LASER SYSTEM

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problems Cataract (1766); Visual Disturbances (2140); Halo (2227)

Event Date 04/22/2023

Event Type  Injury  

Event Description

*lasik flap both eyes 2013.Noticed some minor issues (i.E., halos, starbursts).Vision started to revert after 6 or 7 years.*lasik prk - 2022 in left eye - was supposed to be a touchup.I now have 2 different types of cataracts (regular cataracts in both eyes and an additional posterior subcapsular in my left eye).I believe that i may have had a cataract in both eyes prior to touchup prk surgery.I believe my surgeon may have operated on me without checking for these cataracts first.I am now 51 years old and have 3 college aged children.Please help.Do not allow these surgeries anymore when there is evidence that cataracts will show up earlier because of the surgery.And because my current eye doctor says the cataract surgery carries high risk because of the lasik.Reference report: mw5118365.

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17125679
• MDR Text Key: 317175142
• Report Number: MW5118364
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ESTRADIOL, LEVOTHYROXINE.
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White