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:1/17/2017)... (PRWEB) , ... January 17, 2017 , ... Gym Source, ... of a new showroom at South Dixie Hwy in Miami, FL. , “We are ... Gym Source. “The new innovative in-store concept is designed to give clients a seamless ...
(Date:1/17/2017)... Los Angeles, CA (PRWEB) , ... January 17, ... ... conflicted and concerned by the political/social/economic events, Dr. Carol Francis re-releases powerfully uplifting ... tragedies and magical moments that help everyone endure and pass through tough times, ...
(Date:1/17/2017)... ... January 17, 2017 , ... Kevin Harrington (one of the original Sharks ... DRTV campaigns regarding the topic of Beauty and Personal Care. , ... What better way to commit to these changes than beginning with personal care and ...
(Date:1/17/2017)... ... January 17, 2017 , ... Achieve TMS West, with multiple ... new office in San Clemente, California this month. Achieve TMS West is the ... treating individuals struggling with major depression. Depression impacts over 15 million adults in ...
(Date:1/17/2017)... ... January 17, 2017 , ... Peoples Health is pleased to ... on Dec. 1, 2016. Peoples Health, a Metairie-based Medicare Advantage company, serves more ... addition to our provider network, and the addition will benefit our members in ...
Breaking Medicine News(10 mins):
(Date:1/17/2017)... -- Research and Markets has announced the addition of ... to their offering. ... The global fluoropolymer market in the healthcare industry to grow ... Global Fluoropolymer Market in the Healthcare Industry 2016-2020, has been ... experts. The report covers the market landscape and its growth prospects ...
(Date:1/17/2017)... Tocagen Inc ., a clinical-stage, cancer-selective gene therapy company, today announced ... pharmaceutical development at Tocagen, will present at Phacilitate Cell & ... Miami . Details of the ... ... - what to do when and why Date and Time: Wednesday, ...
(Date:1/17/2017)... 2017 Research and Markets has announced the ... Generic), Manufacturer (Captive, Merchant), Synthesis (Synthetic, Biotech), Product (mAb, Hormone) Drug ... 2021" report to their offering. ... The global active pharmaceutical ingredients market is ... Billion in 2016, growing at a CAGR of 6.3% from 2016 ...
Breaking Medicine Technology: