MAUDE Adverse Event Report: ALCON RESEARCH, LTD. LASIK LASER; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 04/23/2018

Event Type  Injury  

Event Description

Lasik caused all of this.No issues prior.Inescapable pain and discomfort.

• Brand Name: LASIK LASER
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): ALCON RESEARCH, LTD.
• MDR Report Key: 7780316
• MDR Text Key: 117267197
• Report Number: MW5079126
• Device Sequence Number: 0
• 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: 08/09/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 73