MAUDE Adverse Event Report: UNKNOWN LASIK I DESIGN; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Keratitis (1944); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Eye Pain (4467); Increased Sensitivity (4538); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/03/2020

Event Type  Injury  

Event Description

Permanent damage to both eyes following lasik laser eye surgery.Both eyes have dry eye disease, keratitis, meibomian gland dysfunction and corneal neuropathic pain which has developed following lasik.None of these conditions were present in either eye prior to lasik.Symptoms include constant burning pain, foreign body sensation, sensitivity to air and light, redness, dryness, blurry vision.Serious night time vision complications including halos, starbursts and light sensitivity that has results in not being able to drive anymore at night time.No nighttime issues prior to lasik.Complications due to large pupil size not being taken into account when lasik was performed.Optical express.

• Brand Name: LASIK I DESIGN
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17309795
• MDR Text Key: 318964985
• Report Number: MW5119311
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: DRY EYE DROPS.; DRY EYE OINTMENT.; IKERVIS.; LANSOPRAZOLE.; LID SCRUB HYPOCHLOROUS ACID SPRAY.; OMEGA 3 2000MG SUPPLEMENTS
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White