Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
Although CDRH has repeatedly refused in the face of mounting adverse reaction/injury reports to remove the LASIK indication from lasers labeled for that vision-enhancement indication, Center director Jeffrey Shuren 6/10 took less than 40 minutes to tell a LASIK activist CDRH would “look into” a patient’s report that he/she was considering suicide because of LASIK injuries. The call on Shuren came in an email from LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer, who in two months ago launched a nationwide Internet petition for Congress to fire Shuren over the LASIK issue and his purported “capture” by industry.
In her email, Cofer told Shuren she had found the patient’s 5/22 report in CDRH’s MAUDE database, in which the patient said: “I had Lasik 5 years back and it burns like ‘profanity’. Feel I should commit suicide, got conjunctivitis and the conditions worsened. I’m fed up, using tears natural and a steroid. Please help.”
Cofer wrote that she “happened upon this report as I was reviewing the most recent Lasik MedWatch reports contained in the Maude database, which is something that I do routinely in my continuing efforts to raise awareness of the risks of Lasik surgery. Severe burning eye pain as described by this patient is known as corneal neuropathic pain, and it results from damage to corneal nerves during Lasik surgery.
“I am now aware of eight Lasik-related suicides, the most recent being the suicide of Max Cronin, a 27-year-old Iraq war veteran in January of this year. I believe the FDA has a moral, if not a legal, obligation to follow up directly with this patient who has expressly asked for your help. Please reply by e-mail within 3 days to advise that you are taking appropriate steps.”
Shuren’s email response came less than 40 minutes later: “Dear Ms. Cofer, Thank you for raising the report with me. We will look into it. Jeff”