MAUDE Adverse Event Report: LASER; EXCIMER LASER SYSTEM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Type  Injury  

Event Description

Follow on surgery 3x cxl; lasik surgery in (b)(6) 2006.Diagnosed with corneal ectasia in 2011.Prior scans showed a high risk and no warning of this risk.Follow on surgery of collagen cross linking (cxl) to both eyes, right eye in 2012 and 2022, left eye in 2015.Continuous use of hyloforte, fml and opatanol for ongoing symptoms since 2011.Fda safety report id # (b)(4).

• Brand Name: LASER
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 13783608
• MDR Text Key: 287394204
• Report Number: MW5108192
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: CETIRIZINE HYDROCHLORIDE ; FML OPATANOL ; HYLOFORTE; SYMBICORT ; TURBO INHALER
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female
• Patient Race: White