MAUDE Adverse Event Report: UNKNOWN LASIK PRK SURGERY; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Corneal Abrasion (1789); Dry Eye(s) (1814)

Event Date 06/05/2023

Event Type  Injury  

Event Description

I got photorefractive keratectomy laser eye surgery and now my eyes are dry and i get corneal abrasions at night.

• Brand Name: LASIK PRK SURGERY
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17080637
• MDR Text Key: 316811161
• Report Number: MW5118252
• 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: Unknown
• Type of Report: Initial
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: OPTASE HYLONIGHT.
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White