MAUDE Adverse Event Report: LASIK PLUS LASIK; LASIK EYE SURGERY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dry Eye(s) (1814); Red Eye(s) (2038)

Event Date 07/15/2011

Event Type  Injury  

Event Description

Had lasik eye procedure, performed at lasik plus in (b)(6).After one year, i have experienced chronic dry eye syndrome, to the point that my eyes are constantly red and dry and may require further surgery to correct this problem.Lasik eye surgery follow up dates: 1 week, 2 weeks, 3 weeks, one month, 3 months.

• Brand Name: LASIK
• Type of Device: LASIK EYE SURGERY
• Manufacturer (Section D): LASIK PLUS; MO
• MDR Report Key: 3229873
• MDR Text Key: 3687910
• Report Number: MW5030868
• 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: 07/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 54 YR
• Patient Weight: 84