MAUDE Adverse Event Report: UNKNOWN LASIK SURGICAL PROCEDURE; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Corneal Abrasion (1789); Dry Eye(s) (1814); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Eye Pain (4467); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 10/10/2010

Event Type  Injury  

Event Description

I had lasik surgery and immediately experienced it as a severe traumatic injury.I never experienced the vision "correction" promised by the procedure, and instead experienced severe visual symptoms including: dry eyes, eye pain, inability to coordinate vision, dizziness, headaches, light sensitivity, starbursts, halos, diminished night vision, discomfort with driving, severe discomfort with night driving with oncoming headlights, diminished visual abilities as a doctor leading to no longer being able to do certain procedures or surgeries, postural instability, trouble turning head and eyes together without experiencing neck spasms and tension, diminished abilities to use screens (computers/phones) necessary for work, 58% corneal aberration left eye, 28% corneal aberration right eye, needing four or more different pairs of glasses to be able to see at all at any distance and never well or comfortably as i could before the lasik procedure.The net effect is that i have severe eye strain and this has a severe negative effect on my mental processing and acuity which has diminished from superior to inferior/disabling.The doctor who performed the surgery blamed it all on "the healing process" and said that i could have more surgery to see if it would help but that more surgery could also make things worse, and second opinion doctors said that i was better off just learning to live with the disabilities since more surgery would probably not help and just make things worse.I am a doctor myself and i was never properly informed about the true risks and side effects of the lasik procedure.I believe that lasik is dangerous and should be banned because it literally plays russian roulette with patients' vision and overall functioning as human beings.Acceptable corneal aberration is considered less than 25%.Following lasik surgery i have been tested to have 58% corneal aberration in the left eye and 28% corneal aberration in the right eye.All testing was done in 2010/2011.

• Brand Name: LASIK SURGICAL PROCEDURE
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15970439
• MDR Text Key: 305539149
• Report Number: MW5113749
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2022
• Patient Sequence Number: 1
• Treatment: MESALAMINE.; VITAMIN D, B COMPLEX, CALCIUM, IRON.
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic