Navigation Links
New FDA Study Seeks Feedback on Lasik Surgery
Date:10/16/2009

Warnings issued to 17 centers for lax reporting of procedure-related adverse events

FRIDAY, Oct. 16 (HealthDay News) -- The percentage of patients who experience serious quality-of-life problems after Lasik eye surgery is being studied by the U.S. Food and Drug Administration, which has also issued warning letters to a number of Lasik facilities that weren't properly reporting problems with the procedure.

The FDA study, which will also identify factors that predict quality-of-life problems in Lasik patients, has three phases. Phase 1, launched in July 2009, involves the design and launch of a Web-based questionnaire to assess patient-reported outcomes and evaluate quality-of-life issues after the laser-assisted eye surgery.

Phase 2 will examine quality of life and satisfaction among patients treated at the Navy Refractive Surgery Center, and phase 3 will be a national, multi-center clinical trial to study quality of life after Lasik among the general population.

"This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects from the procedure," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said in an agency news release.

If the study identifies any problems with the safety or effectiveness of the lasers used in Lasik surgery, the agency will evaluate whether any action is necessary.

In related news, the FDA also noted in the release that it issued warning letters to 17 Lasik ambulatory surgical centers after inspections revealed that the centers had inadequate systems for reporting problems suffered by patients. The types of problems were specified.

"Many people in the U.S. undergo Lasik procedures. Ambulatory surgical centers that perform Lasik must maintain a robust reporting system as required by law," Shuren said in the news release. "Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in Lasik procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."

More information

The FDA has more about Lasik eye surgery.



-- Robert Preidt



SOURCE: U.S. Food and Drug Administration, news release, Oct. 15, 2009


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Penn study finds pro-death proteins required to regulate healthy immune function
2. New study shows promise in reducing surgical risks associated with surgical bleeding
3. Study, meta-analysis examine factors associated with death from heatstroke
4. Study suggests loss of 2 types of neurons -- not just 1 -- triggers Parkinsons symptoms
5. Study says COPD testing is not measuring up
6. Preclinical study suggests organ-transplant drug may aid in lupus fight
7. Ability to cope with stress can increase good cholesterol in older white men, study finds
8. High alcohol consumption increases stroke risk, Tulane study says
9. Mailman School of Public Health study examines link between racial discrimination and substance use
10. Pitt study finds inequality in tobacco advertising
11. Stanford study highlights cost-effective method of lowering heart disease risks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... (PRWEB) , ... February 22, ... ... Adjustment solution leverages advanced data analytics to accurately understand each Medicare Advantage ... reimbursement for a given population. This new solution helps transform the HCC ...
(Date:2/22/2017)... ... February 22, 2017 , ... Doctors on Liens is continuing ... ophthalmologist, Dr. Steven H. Rauchman, practicing at North Valley Eye Medical Group in ... liability, premise liability and other personal injury cases. These injuries have a major ...
(Date:2/22/2017)... ... February 22, 2017 , ... Using the power of ... a simple online checklist. Over a period of just 24 months, thousands of individuals ... an online checklist called T.A.D. , “The internet is not getting quieter. In fact ...
(Date:2/22/2017)... ... February 22, 2017 , ... ... Quality Insights to help small practices in Delaware, New Jersey, Pennsylvania and West ... the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). , This ...
(Date:2/22/2017)... ... February 22, 2017 , ... A product of digesting ... to derive a heart-protective benefit from eating soy foods, while others do not, a ... who are able to produce equol—a substance made by some types of “good” gut ...
Breaking Medicine News(10 mins):
(Date:2/22/2017)... 2017 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK ... Quarter 2016 investor conference call and webcast at 8:30 a.m., ... call will cover an update on Merrimack,s recent progress as ... 2016 financial results. A press release detailing the information to ... of Wednesday, March 1. Investors and the general public are ...
(Date:2/22/2017)... , Feb. 22, 2017 Summary ... heart failure partnering deals and agreements entered into ... the full report: http://www.reportlinker.com/p03605673-summary/view-report.html Description ... report provides understanding and access to partnering deals ... healthcare companies. - Trends in partnering ...
(Date:2/22/2017)... NEW YORK , Feb. 22, 2017 ... non-small cell lung cancer partnering deals and agreements entered ... the full report: http://www.reportlinker.com/p03605668-summary/view-report.html Description The ... since 2010 report provides understanding and access to partnering ... healthcare companies. - Trends in partnering deals ...
Breaking Medicine Technology: