MAUDE Adverse Event Report: PRK LASER MACHINE; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Pain (1994); Visual Disturbances (2140)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Had prk lasik surgery done and it has ruined my eyes.Severe complications.This effects my ability to work and do normal day to day activities.I have a severe case of photophobia followed by ocular pain.Chronic dry eyes.(b)(6) eye center.Fda safety report id # (b)(4).

• Brand Name: PRK LASER MACHINE
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• MDR Report Key: 12689348
• MDR Text Key: 278569643
• Report Number: MW5104923
• Device Sequence Number: 1
• Product Code: OTL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 27 YR
• Patient Weight: 75