MAUDE Adverse Event Report: LASIK PLUS; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Halo (2227)

Event Date 01/11/2018

Event Type  Injury  

Event Description

Had monovision lasik at lasik plus to correct nearsightedness with astigmatism.Since procedure (about 6 months ago).I have chronic problems with glare and halos, which are noticeably worse at night.Correct vision and eliminate need for glasses.

• Brand Name: LASIK PLUS
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 7665760
• MDR Text Key: 113497997
• Report Number: MW5078279
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 43 YR
• Patient Weight: 86