http://lasiknewswire.com LASIK News and Information Sun, 24 Aug 2008 18:53:19 +0000 http://backend.userland.com/rss092 en Jenna Reed and Rian Reed vs. Alcon Laboratories, Inc., Alcon Manufacturing, Ltd., and Alcon Refractive Horizons, Inc. United State District Court, District of Colorado. Denver, CO (LASIK Newswire) August 24, 2008 -- On August 20, 2008, plaintiffs, Jenna Reed and Rian Reed, filed their complaint in the United States District Court, ... http://lasiknewswire.com/2008/08/24/alcon-sued-for-products-liability-due-to-recall-of-defective-ladar6000-excimer-laser/ This letter addresses my concern about the safety of LASIK surgery. I have practiced ophthalmology for thirty-three years. After taking all the courses on LASIK, I decided not to do the surgery.  I believe LASIK surgery is not consistent with the ophthalmologist's hypocritic oath of "first do no harm. " Statistics ... http://lasiknewswire.com/2008/08/09/ophthalmologist-tells-the-fda-that-lasik-is-russian-roulette/ Ask any LASIK patient if he or she was given the FDA-mandated Patient Information Booklet prior to surgery.  The answer is usually "no".  Companies that manufacture lasers for use in LASIK surgery are required by the FDA to provide Patient Information Booklets to LASIK surgeons.  In turn, LASIK surgeons are required ... http://lasiknewswire.com/2008/07/27/lasik-surgeons-fail-to-comply-with-fda-rules-to-inform-patients-of-risks/ MIAMI, FLORIDA -- A new study published in the July, 2008 edition of Archives of Ophthalmology demonstrates an elevated risk of suicide in people with visual impairment.   The psychosocial and health consequences of ocular conditions that lead to visual impairment (VI) are broad and include impaired activities of daily living,  social isolation, cognitive ... http://lasiknewswire.com/2008/07/19/study-finds-link-between-visual-impairment-and-suicide/ FOR IMMEDIATE RELEASE  July 15, 2008 Corneal ectasia; thousands of late onset complications of LASIK likely LASIK surgeons fail to comply with FDA reporting requirement After recklessly performing millions of LASIK surgeries over the past decade with little to no policing of its poor surgical practices and deceptive advertising, the LASIK industry is feeling the ... http://lasiknewswire.com/2008/07/15/thousands-of-severe-complications-of-lasik-likely/ Gaithersburg, MD April 25, 2008  FDA HEARING PRESENTATION OF LAURANELL H. BURCH I appreciate the opportunity to speak at this FDA hearing on post-market LASIK issues. My name is Lauranell Burch. I have a Ph.D. in Molecular Biology and Genetics and have been a medical researcher for over 20 years. I am trained ... http://lasiknewswire.com/2008/07/02/medical-research-scientist-calls-for-moratorium-on-lasik-at-fda-hearing/ May 19, 2008 Dockets Management Branch Food and Drug Administration Room 1061 5630 Fishers Lane Rockville, MD 20852 Citizen Petition The undersigned submits this petition to: 1) ban the use of all refractive surgery lasers for LASIK surgery due to substantial deception in the labeling and an unreasonable and substantial risk of injury, and 2) acknowledge and enforce remedy ... http://lasiknewswire.com/2008/07/02/medical-research-scientist-submits-citizen-petition-to-the-fda-calling-for-a-ban-on-lasers-for-lasik/ For Immediate Release Reports of LASIK complications to the FDA's MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the ... http://lasiknewswire.com/2008/06/16/did-the-fda-and-ascrs-knowingly-misrepresent-the-numbers-of-bad-lasik-outcomes/ Amid bad publicity for the LASIK industry, a group of LASIK surgeons announced preliminary findings from an unpublished review of medical studies showing a "95.4% global LASIK satisfaction rate".    Press releases issued by LASIK industry insiders appeared to link this literature review to the FDA with misleading statements such as, "The ... http://lasiknewswire.com/2008/05/31/lasik-industry-deceives-the-public-with-smoke-and-mirrors/ May 10, 2008 Daniel Schultz, M.D. Director, Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, MD 20850 Dear Dr. Schultz: I was initially encouraged to see the FDA take action by convening an advisory panel on April 25, 2008 to conduct a hearing on LASIK post-market issues including the impact on ... http://lasiknewswire.com/2008/05/12/patient-sends-letter-to-daniel-schultz-md-fda-cdrh-director-regarding-lasik/ FOR IMMEDIATE RELEASE SynergEyes 2232 Rutherford Road Carlsbad, CA 92008 Ph: 877-733-2012 Fax: 877-329-2012 Contact: Kellie Kaseburg Vice President of Global Marketing kkaseburg@synergeyes.com 877.SEE.2012 SynergEyes Hybrid Contact Lenses Provide a Vision Solution for Post-LASIK Patients San Diego, CA (April 25, 2008) – SynergEyes, Inc., of Carlsbad, CA, recently launched a revolutionary hybrid contact lens designed for people who need further vision correction ... http://lasiknewswire.com/2008/05/06/synergeyes-hybrid-contact-lenses-provide-a-vision-solution-for-post-lasik-patients/ LASIK is a 2.5 billion dollar per year industry.  LASIK is considered by some as the “gravy train” of ophthalmology.  Recently many questions have been raised about the frequency and severity of complications, and now many are wondering if LASIK really lives up to the hype.   In the past decade, several ... http://lasiknewswire.com/2008/05/04/patients-feel-fda-is-disingenuous-about-interest-in-lasik-complications/ Cornea. 2005 Jan;24(1):92-102. Pathologic findings in postmortem corneas after successful laser in situ keratomileusis. Kramer TR, Chuckpaiwong V, Dawson DG, L'Hernault N, Grossniklaus HE, Edelhauser HF. Emory Eye Center, Emory University, Atlanta, GA 30322, USA. Theresa_Kramer@emoryhealthcare.org PURPOSE: To examine the histologic and ultrastructural features of human corneas after successful laser in situ keratomileusis (LASIK). METHODS: Corneas ... http://lasiknewswire.com/2008/05/03/study-reveals-permanent-damage-in-all-post-lasik-corneas/ National Public Radio 5/1/2008  The FDA says it's not certain how many LASIK patients have problems with their vision weeks or months after their surgeries. But the agency is planning a new study, scheduled to begin next year, to get a better handle on the prevalence. Individual consumers can also report ... http://lasiknewswire.com/2008/05/03/fda-encourages-patients-with-visual-difficulties-halos-starbursts-night-vision-problems-to-file-an-adverse-event-report/ Cornea. 2007 Apr;26(3):246-54. Outcomes of LASIK for myopia with FDA-approved lasers. Bailey MD, Zadnik K. The Ohio State University College of Optometry, Columbus, OH 43210 , USA. mbailey@optometry.osu.edu PURPOSE: To report expected outcomes of laser in situ keratomileusis (LASIK) for myopia and myopic astigmatism from existing US Food and Drug Administration (FDA) data. METHODS: Data ... http://lasiknewswire.com/2008/05/03/fda-clinical-trials-show-20-complication-rate-six-months-after-lasik/ "After listening to hours of patient horror stories Friday, an advisory panel recommended that federal regulators strengthen safety warnings for vision-correcting laser eye surgery. The panel recommended that laser manufacturers add several risk factors to their patient information and that the Food and Drug Administration improve its online consumer information ... http://lasiknewswire.com/2008/05/03/the-news-observer-04262008-panel-wants-warning-for-lasik-users/ J Refract Surg. 2005 Sep-Oct;21(5):433-45. Cohesive tensile strength of human LASIK wounds with histologic, ultrastructural, and clinical correlations. Schmack I, Dawson DG, McCarey BE, Waring GO 3rd, Grossniklaus HE, Edelhauser HF. Emory Eye Center, Emory University School of Medicine, Atlanta, GA 30322, USA. PURPOSE: To measure the cohesive tensile strength of human LASIK corneal ... http://lasiknewswire.com/2008/05/03/lasik-flap-only-heals-to-2-of-normal-corneal-strength/ Am J Ophthalmol. 2007 Apr;143(4):629-34.   Methicillin-resistant Staphylococcus aureus infectious keratitis following refractive surgery. Solomon R, Donnenfeld ED, Perry HD, Rubinfeld RS, Ehrenhaus M, Wittpenn JR Jr, Solomon KD, Manche EE, Moshirfar M, Matzkin DC, Mozayeni RM, Maloney RK. Ophthalmic Consultants of Long Island, Rockville Centre, New York 11570, USA. PURPOSE: To elucidate risk factors, ... http://lasiknewswire.com/2008/05/03/methicillin-resistant-staphylococcus-aureus-mrsa-infectious-keratitis-following-refractive-surgery/ 1. LASIK causes dry eye Dry eye is the most common complication of LASIK. Corneal nerves that are responsible for tear production are severed when the flap is cut. Medical studies have shown that these severed nerves never return to normal densities and patterns. Symptoms of dry eye include pain, burning, ... http://lasiknewswire.com/2008/04/28/top-ten-reasons-not-to-have-lasik-surgery/ Click here to go to the home page of THE LASIK REPORT   THE LASIK REPORT A Call for the Discontinuation of a Harmful Procedure Revised April, 2008 LASIK is one of the most commonly performed elective surgeries in the United States today.  The public perception of LASIK is based largely on advertising, which is intended ... http://lasiknewswire.com/2008/04/13/latest-version-of-the-lasik-report-released-days-before-fda-hearing-to-consider-lasik-complaints/