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 t
'/>"/>

Copyright©2009 ScoutNews,LLC.
All rights reserved

Page: 1 2

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:9/1/2015)... ... September 01, 2015 , ... Stress comes in many different ... life changes can lead to very serious, life-altering events. Fortunately nature offers a ... Herbal supplement manufacturer MediHerb has coupled therapeutic doses of Rhodiola and ...
(Date:9/1/2015)... Bronx, NY (PRWEB) , ... September 01, 2015 , ... ... for 86 children and teenagers, from ages 6-18. Calvary’s Camp Compass® has taken place ... camp staff included 65 adult counselors, some of whom work for Calvary, and two ...
(Date:9/1/2015)... , ... September 01, 2015 , ... Horizon Blue Cross ... 50 Best Companies for Latinas in the LATINA Style 50 Report that recognizes companies ... , For 2015, Horizon BCBSNJ climbs from number 24 to 21 of ...
(Date:9/1/2015)... ... September 01, 2015 , ... ... efficiently cure and prevent different malignancies. Some options for cancer treatment are ... due to which distinctive approach is necessary for effective treatment. Several molecules ...
(Date:9/1/2015)... ... September 01, 2015 , ... ... Blue Cross and Blue Shield of Minnesota (Blue Cross) has announced Doctor On ... Based in San Francisco, Doctor On Demand provides immediate access to Board Certified ...
Breaking Medicine News(10 mins):Health News:MediHerb Launches New Herbal Supplement to Help with the Challenges of Everyday Life 2Health News:MediHerb Launches New Herbal Supplement to Help with the Challenges of Everyday Life 3Health News:Calvary Hospital Hosts 18th Annual Bereavement Camp 2Health News:Calvary Hospital Hosts 18th Annual Bereavement Camp 3Health News:Horizon Blue Cross Blue Shield of New Jersey Named One of the 50 Best Companies for Latinas by Latina Style Magazine 2Health News:Horizon Blue Cross Blue Shield of New Jersey Named One of the 50 Best Companies for Latinas by Latina Style Magazine 3Health News:CD Antigen Cancer Market and Pipeline Landscape Examined in Comprehensive Kuick Research Report Published at MarketPublishers.com 2Health News:CD Antigen Cancer Market and Pipeline Landscape Examined in Comprehensive Kuick Research Report Published at MarketPublishers.com 3Health News:Blue Cross and Blue Shield of Minnesota names Doctor On Demand as preferred telehealth destination 2Health News:Blue Cross and Blue Shield of Minnesota names Doctor On Demand as preferred telehealth destination 3
... that Sienna Miller's determination to make her sex scenes look ... ,The Factory Girl star recently admitted that she got ... new movie 'Interview' with co-star Steve Buscemi. ,The ... a kitchen sideboard. ,"We were making out and ...
... but according to a psychological study conducted in the United States, ... we age. ,Researchers at Washington University in St Louis ... 80s and another in their early 20s the same opening lines ... of four endings. ,While one answer was the expected ...
... in the occurrence of anaphylaxis between the northern and ... can be fatal without treatment with epinephrine. The ... anaphylaxis risk, currently are without explanation. The investigators hypothesize, ... of sunshine, may play a role and that this ...
... from the University of Havana have found that two ... and bio-stimulant properties. ,The researchers said that ... with great healing and antiseptic properties, as well as ... ,Chitin is a very common polymer present in ...
... the five year-old HUGO Borbilas was leaning on the mailbox ... when he lost his footing and became impaled on ... into his throat, narrowly missing his carotid artery, oesophagus, windpipe, ... just stopping short of his brain. ,Doctors say ...
... has lunched a scathing attack on Hollywood star Eddie Murphy and ... colleague Mel B in a callous way after she got pregnant ... actor in a new TV show that will be sired soon. ... dick off too, the News of the World quoted her, as ...
Cached Medicine News:Health News:Large Geographic Differences in EpiPen Prescriptions in the U. S. 2Health News:Lobster Shells Have Great Healing and Antiseptic Properties 2Health News:Miraculous Recovery for Australian Child Whose Throat was Speared 2
(Date:9/1/2015)... --NOWDiagnostics Inc., based in Springdale, Ark. , ... Canada , a move that brings the company ... have greater access to information concerning their health. ... blood-based rapid tests that allow health care providers to ... ailments and diseases. ZBx Corporation, a Toronto ...
(Date:9/1/2015)... , Sept. 1, 2015 Konica Minolta ... Computed Radiography (CR) system, designed to deliver enterprise level ... utilizing the same Control Station as the Konica Minolta ... with an upgrade path from CR to DR. The ... to help improve workflow with unparalleled reliability and high ...
(Date:9/1/2015)... VEGAS , Sept. 1, 2015  Dr. ... DigiPath Labs , the cannabis testing subsidiary of DigiPath, ... Patients Group about the lack of consistency in ... the online resource for medical cannabis information, she explained ... patients because their lack of uniform requirements makes standardization ...
Breaking Medicine Technology:NOWDiagnostics Inc. Acquires Canada's ZBx Corporation 2NOWDiagnostics Inc. Acquires Canada's ZBx Corporation 3Konica Minolta Launches New CR System with Low-Cost Upgrade Path to DR 2DigiPath Labs CSO Dr. Cindy Orser Calls for Uniform Standards for Cannabis Safety Testing 2DigiPath Labs CSO Dr. Cindy Orser Calls for Uniform Standards for Cannabis Safety Testing 3
... the ADA,s Annual Scientific Sessions, SAN FRANCISCO, ... of the dose-finding study for its new,injectable diabetes ... American Diabetes Association,s (ADA) 68th Annual Scientific Sessions,meeting ... that AVE0010 was well tolerated and significantly,improved glycemic ...
... California, June 6 , - "ADVANCE Results ... the world,s largest ever study of diabetes treatments,show ... release,gliclazide and other drugs as required, protects patients ... treatment reduces,the risk of kidney disease by one-fifth. ...
Cached Medicine Technology:New Diabetes Compound AVE0010 Showed Clear Dose Response Results With Once-A-Day Injection in Phase IIb Study 2New Diabetes Compound AVE0010 Showed Clear Dose Response Results With Once-A-Day Injection in Phase IIb Study 3New Diabetes Compound AVE0010 Showed Clear Dose Response Results With Once-A-Day Injection in Phase IIb Study 4The Largest Ever Study of Diabetes Shows Intensive Glucose Control Reduces Serious Complications 2
... ergonomic chairs with concave seats ... support • Select options like ... and glides. • BTT/1P chairs ... environments: industry, education, laboratory, clean ...
... with concave seats and standard-sized ... Select options like seats, backrests, ... • BTT/1P chairs are recommended ... education, laboratory, clean room, static ...
... chairs with concave seats and large ... options like seats, backrests, armrests, and ... BE Series for top performance in ... education, laboratory, clean room, static control, ...
... ergonomic chairs with concave seats and ... Select options like seats, backrests, armrests, ... the BE Series for top performance ... industry, education, laboratory, clean room, static ...
Medicine Products: