Refractive Surgery News

CRSQA Files Bankruptcy Petition to Halt Patient Lawsuits for Criminal Activity

On July 21, 2010, the "Council for Refractive Surgery for Quality Assurance" (USAEyes) filed a Chapter 11 Bankruptcy Petition.  The petition lists three creditors (IRS, Dr. Lauranell Burch, and Brent Hanson), assets of $1,222, and liabilities of $5,716.71.  Glenn Hagele, the Executive Director of USAEyes filed the Bankruptcy Petition to shield USAEyes from liability for widespread criminal acts committed by himself and the organization, which included burglaries of a patient's residence, wiretapping, theft of financial documents, and a scheme to...
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FDA Review: 1 of 5 LASIK Patients Suffer Serious Complications

After researching all of the publicly accessible FDA documentation and a large amount of non-FDA literature, including peer-reviewed journals, correspondence between informed parties, and federal court documents, it is my carefully considered opinion that these lasers and associated hardware were respectively PMA-approved and 510(k)-cleared by FDA with egregiously insufficient evidence of their long-term safety and effectiveness for the LASIK indication.
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FDA Mismanagement of Lasers Used in LASIK Eye Surgery Described by Former Regulator

Excerpts of a letter from Morris Waxler, a former FDA regulator, to Dean Kantis show how the FDA mismanaged its approval of lasers used in LASIK eye surgery: LASIK-induced eye injuries occur, in part, because FDA did not ensure that manufacturers have adequate design controls, fault tree analyses, and correction and prevention procedures, including, but not limited to, adverse event definitions, MDR reportable events, trend analysis, and root cause analyses. The agency also did not compare the safety and effectiveness...
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Former FDA Regulator Says LASIK Side Effects Weren't Taken Seriously Enough

By Lisa Start, Alberto Orso, Joseph Brownstein LASIK eye surgery has provided the promise of a quick vision fix for millions of Americans, but now one of the Food and Drug Administration regulators who approved the procedure in the 1990s is publicly expressing concerns about its safety. Some 700,000 people a year in the U.S. get LASIK surgery to correct their vision, and in the years since the procedure was approved, the majority of patients have been happy with...
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Dr. Quentin Franklin and LASIKPLUS Sued for LASIK Malpractice

Laurie Shrieves v. Quentin Franklin, M.D., and LCA-Vision, Inc. d/b/a LASIKPlus Virginia Circuit Court for the City of Chesapeake, Case No. CL 10000278-00 Pleasantville, NY (PRWEB) February 14, 2010 -- On February 5, 2010, plaintiff, Laurie Shrieves, filed suit against Quentin Franklin, M.D., and VCA-Vision, Inc., d/b/a LASIKPlus, in the Virginia Circuit Court for the City of Chesapeake, for the negligent performance of LASIK surgery on Ms. Shrieves. On June 29, 2008, Ms. Shrieves came under the care and...
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Dr. Gerald Horn Charged with Inside Trading by the SEC

By Hemma Ramrattan on February 12, 2010, 1:56 pm The SEC has charged ophthalmologist Gerald Horn with insider trading in the options of LCA-Vision Inc., a provider of laser eye surgery. Horn (pictured), the medical director of LCA’s Schaumburg, Illinois facility, reportedly faces civil charges over his purchases of options on the shares of LCA by which he made a profit of about $870,000. By exercising stock option grants and immediately selling this stock on the basis of nonpublic information,...
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SLAPP Lawsuit Against 100 LASIK Patients by CRSQA Dismissed

On April 7, 2009 Glenn Hagele and the Council for Refractive Surgery Quality Assurance, filed a frivolous SLAPP lawsuit against Dr. Lauranell Burch and 100 LASIK patients in an effort to silence their complaints on the internet about medical malpractice.  On February 8, 2010, the court ordered the lawsuit against Dr. Lauranell Burch and 100 patients to be dismissed with prejudice. This means that CRSQA can never again refile this lawsuit in an effort to intimidate and silence LASIK patients....
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Dr. Nicholas Caro Barred from Performing LASIK Eye Surgery

By Deborah L. Shelton, Tribune reporter 8:25 PM CST, February 19, 2010 A state regulatory agency is barring a Chicago ophthalmologist from performing Lasik eye surgeries in Illinois, one of a number of disciplinary actions taken against the doctor on Friday. After finding that Dr. Nicholas Caro had engaged in unprofessional conduct and gross negligence, the Illinois Department of Financial and Professional Regulation suspended his medical license for 30 days, placed him on probation for a minimum of 3 years...
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LASIK Surgery Chain in Florida Goes Bankrupt

South Florida Business Journal - by Paul Brinkmann Vision Care Holdings, operator 30 Lasik surgery clinics, filed for Chapter 11 bankruptcy protection Thursday. The Lake Worth-based company said it has between $50 million and $100 million in debt, and less than $10 million in assets. The company’s once operated more than 90 optical service stores in 30 states, including Vision Care, Eyeglass World and Lasik Institute locations. An attorney for the company, Matt Zifrony, said it sold the Eyeglass World...
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Glenn Hagele's Criminal Conduct Cited in Attorney's Motion to Withdraw from USAEYES/CRSQA Lawsuit

Glenn Hagele filed a frivolous lawsuit against Dr. Lauranell Burch in North Carolina in December 2007.  On December 14, 2009 Jonathan Sasser, the attorney for Glenn Hagele, filed a motion to withdraw from representation and cited the following provisions of North Carolina Rules of Professional Conduct: 1.16(b(3) 1.16(b)(4) 1.16(b(5),  The portion of the North Carolina Rules of Professional Conduct which Jonathan Sasser cited is: Rule 1.16 Declining or Terminating Representation (a) Except as stated in paragraph (c), a lawyer shall...
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Dr. Mark Whitten, Dr. Edward Perraut, and TLC Sued for Medical Malpractice

Jamie Domeier vs. Mark Whitten, M.D., L. Edward Perraut, Jr. M.D., TLC The Laser Center (Northeast) Inc., Jo Angeles, O.D., Andrew Morgenstern, O.D., Greg W. McGrew, O.D., Paul J. Chmielewski, O.D., and Eyecare Center Of Leesburg, P.C. Virginia Circuit Court of Fairfax County Case # CL 2009-2959 DR. MARK WHITTEN, DR. L. EDWARD PERRAUT, M.D., & TLC SUED FOR LASIK MALPRACTICE - On August 7, 2009 plaintiff, Jamie Domeier, served her Complaint against Mark Whitten, M.D., L. Edward Perraut, Jr.,...
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Dr. Jack Holladay Accused of Perjury and Fraud by Bankruptcy Trustee

Debtor knowingly and fraudulently made false oaths when he signed and executed his original Schedules that excluded a number of items of substantial value and otherwise contained incorrect information. Debtor further made false oaths at the 341 Meeting of Creditors when he testified that his Schedules were true and correct and when he testified under oath that nothing at his Bellaire home was of any value. He made a further false oath when he testified at the 341 Meeting of Creditors that he specifically recalled not executing any financial statement to Bank of America, when in fact he did provide such a financial statement, which statement was withheld from HEA for 5 months.
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U.S. Warns LASIK Clinics Over Failure to Report Side Effects

By Susan Heavey WASHINGTON (Reuters) - More than a dozen LASIK eye centers have poor systems in place to report any side effects in patients who have undergone the vision correction surgery, U.S. health regulators said on Thursday. There were no problems found with the laser devices used in the procedure, but U.S. Food and Drug Administration inspectors found problems with side-effect reporting systems at 17 LASIK vision correction centers. Warning letters were sent to the clinics, including some TLC...
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Dr. Thomas Tooma Violates FDA Safety Protocols (again)

  Laser Eye Care of California 10/09/09     Department of Health and Human Services Public Health Service Food and Drug Administration   10903 New Hampshire Avenue Silver Spring, MD 20993 OCT 09 2009 WARNING LETTER VIA FEDERAL EXPRESS Dr. Tom Tooma Owner Laser Eye Care of California 16255 Ventura Blvd. Suite 100 Encino, California 91436 Dear Dr. Tooma: During an inspection of your facility located in Encino, California on June 11, 2009, an investigator from the United States Food...
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