MAUDE Adverse Event Report: LASIK; NONE

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Eye Injury (1845); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Phototoxicity (2165); Disability (2371)

Event Type  Injury  

Event Description

I wish to report 21 post lasik/prk pts who developed a previously unreported, severely disabling and possibly permanent complication of the massive corneal nerve fiber axotomies performed during these procedures: it is an especially intense unrelenting form of neuropathic trigeminal pain including in many, painful photosensitivity.This pain had persisted 2 to 15 years at the time of the initial consultation.Because the suicide provoking intensity and unrelenting nature of the pain is masked by the typically normal appearance of these eyes and sometimes a significant delay in their onset, these symptoms have been dismissed as exaggerated or imagined.To my knowledge, this complication has not been previously reported.Despite my paper having been vetted by two neuroscientist-clinician experts on neuropathic pain, the paper was summarily rejected by the journal of the academy of ophthalmology and journal of cataract and refractive surgery.In both cases it appeared that the reviewers were surgeons who currently perform this procedure.My suggestion that one of the reviewers be an expert in neuropathic pain was ignored by both journals.Because of my concern that these rejections may have been motivated by self-interest, i have posted the paper on the website of my nonprofit (b)(6) eye pain.The paper can be accessed from the (b)(6).However, i would like to send you a pdf for your records and will do so if you will send me the appropriate email address where you can receive it.Mine is (b)(6).

• Brand Name: LASIK
• Type of Device: NONE
• MDR Report Key: 3313897
• MDR Text Key: 3703222
• Report Number: MW5031594
• Device Sequence Number: 1
• Product Code: LZS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2013
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening