MAUDE Adverse Event Report: LASIK

Device Problem Insufficient Information (3190)

Patient Problems Retinal Detachment (2047); Blurred Vision (2137); Visual Impairment (2138)

Event Date 02/20/2014

Event Type  Other  

Event Description

Caller reports he had lasik surgery performed in his right eye in (b)(6) of 2014.Two days after the procedure he reports that his vision started to become distorted and darker.Caller states he went to the doctor and found that his retina was detached and an emergency surgery was performed on (b)(6) 2014.Caller reports that he is still experiencing vision issues.

• Brand Name: LASIK
• Type of Device: LASIK
• MDR Report Key: 3983418
• MDR Text Key: 20756901
• Report Number: MW5037609
• Device Sequence Number: 1
• Product Code: LZS
• 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: 08/01/2014

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?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2014
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 100