MAUDE Adverse Event Report: PRK LASER; EXCIMER LASER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Depression (2361)

Event Date 01/10/1999

Event Type  Injury  

Event Description

Had prk with dr (b)(6); 4 years later started with neuropathic pain.Was finally diagnosed in 2013 in (b)(6) with dr (b)(6).Prior to diagnosis, was suicidal.Although better, still experience pain and other side effects and have been unable to work as a mortgage lender for years.Disability initially covered me but continued to harass me and finally discontinued benefits.I chose not to fight in court as was too mentally painful.

• Brand Name: PRK LASER
• Type of Device: EXCIMER LASER
• MDR Report Key: 8228266
• MDR Text Key: 132422506
• Report Number: MW5082935
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/07/2019

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FLAX; LUBRICATING DROPS; OMEGA 3; RESTASIS; SERUM TEARS; STEROID DROPS
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 57