Contact Lens Weares READ!!!!!!!!
#1
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Contact Lens Weares READ!!!!!!!!
Bausch & Lomb Temporarily Suspends U.S. Shipments of ReNu® with MoistureLoc® Produced at Greenville, S.C., Manufacturing Facility Pending Investigation of Reports of Fusarium Infections Among Contact Lens Wearers
FOR RELEASE MONDAY, APRIL 10, 2006
Rochester, NY --- Bausch & Lomb (NYSE:BOL) announced today that it is temporarily suspending U.S. shipments of ReNu® with MoistureLoc® produced at its Greenville, S.C., manufacturing facility in order to facilitate the further investigation of reports of fungal keratitis infections among contact lens wearers in the United States. This action does not affect any other Bausch & Lomb products. Today's announcement follows the release of a report by the U.S. Centers for Disease Control and Prevention that it is reviewing reports of 109 cases of suspected fungal keratitis. The CDC reports that the majority of cases have yet to be reviewed, but of the 30 cases reviewed to date, 28 involved contact lens wearers. Twenty-one reported using ReNu brand contact lens care products and 5 reported using a combination of ReNu and products manufactured by other companies. Bausch & Lomb has been collaborating with the U.S. Food and Drug Administration, the CDC, major eye centers and health authorities in a comprehensive investigation to determine if the reports represent an increase in the historical incidence of these infections, and to determine the root cause.
"Bausch & Lomb's first priority is the health and safety of consumers," said Ronald L. Zarrella, chairman and CEO of the company. "The CDC data released today are both troubling and perplexing, as there is an apparent disproportionate representation of U.S. manufactured ReNu with MoistureLoc in the underlying data. The source of these infections has not been determined. Based on our extensive testing, analysis and further internal reviews, and communications with leading experts, the available scientific evidence does not establish any type of ReNu solution as a cause.
"The CDC has not determined if these reports represent an increase of Fusarium keratitis infections and is continuing to investigate the association, if any, of these cases with any product. Nonetheless, in the interest of public health, we will voluntarily suspend U.S. shipments of ReNu with MoistureLoc while we pursue all appropriate steps to bring this investigation to a definitive conclusion," Zarrella concluded.
They have a press release on their website. Give the other guys a heads up.
FOR RELEASE MONDAY, APRIL 10, 2006
Rochester, NY --- Bausch & Lomb (NYSE:BOL) announced today that it is temporarily suspending U.S. shipments of ReNu® with MoistureLoc® produced at its Greenville, S.C., manufacturing facility in order to facilitate the further investigation of reports of fungal keratitis infections among contact lens wearers in the United States. This action does not affect any other Bausch & Lomb products. Today's announcement follows the release of a report by the U.S. Centers for Disease Control and Prevention that it is reviewing reports of 109 cases of suspected fungal keratitis. The CDC reports that the majority of cases have yet to be reviewed, but of the 30 cases reviewed to date, 28 involved contact lens wearers. Twenty-one reported using ReNu brand contact lens care products and 5 reported using a combination of ReNu and products manufactured by other companies. Bausch & Lomb has been collaborating with the U.S. Food and Drug Administration, the CDC, major eye centers and health authorities in a comprehensive investigation to determine if the reports represent an increase in the historical incidence of these infections, and to determine the root cause.
"Bausch & Lomb's first priority is the health and safety of consumers," said Ronald L. Zarrella, chairman and CEO of the company. "The CDC data released today are both troubling and perplexing, as there is an apparent disproportionate representation of U.S. manufactured ReNu with MoistureLoc in the underlying data. The source of these infections has not been determined. Based on our extensive testing, analysis and further internal reviews, and communications with leading experts, the available scientific evidence does not establish any type of ReNu solution as a cause.
"The CDC has not determined if these reports represent an increase of Fusarium keratitis infections and is continuing to investigate the association, if any, of these cases with any product. Nonetheless, in the interest of public health, we will voluntarily suspend U.S. shipments of ReNu with MoistureLoc while we pursue all appropriate steps to bring this investigation to a definitive conclusion," Zarrella concluded.
They have a press release on their website. Give the other guys a heads up.
#4
Gets Weekends Off
Joined APC: Mar 2006
Posts: 3,333
It’s ok but there are some rules to follow. Lots of good info here:
http://www.aviationmedicine.com/arti...7&contentID=67
(From FAA Policy link)
“Once the vision is stabilized (at least two exams a week apart without changes in acuity), the pilot/controller should have the ophthalmologist complete FAA Form 8500-7, Report of Eye Evaluation. If the vision corrects to 20/20 and there are no complications from the procedure (corneal scarring, night glare, haziness of vision, fluctuating visual acuity), pilots may return to flying and report the surgery at the time of their next FAA physical. This is a change in the previous FAA policy of having to report the surgery to the FAA and obtaining written clearance prior to flying. Controllers are advised to discuss the procedure with the Region Flight Surgeon (RFS) prior to surgery, and will require specific clearance from the RFS before returning to controlling. Typically controllers are given Special Consideration with follow up required at 6 months, and then can be returned to general eligibility.”
- Then again, nobody follows these rules anyway; I was told by a doctor the FAA believes less than 10% of pilots who’ve had a Lasic surgery performed had actually notified them.
Ps. Not me, still considering having the surgery done
http://www.aviationmedicine.com/arti...7&contentID=67
(From FAA Policy link)
“Once the vision is stabilized (at least two exams a week apart without changes in acuity), the pilot/controller should have the ophthalmologist complete FAA Form 8500-7, Report of Eye Evaluation. If the vision corrects to 20/20 and there are no complications from the procedure (corneal scarring, night glare, haziness of vision, fluctuating visual acuity), pilots may return to flying and report the surgery at the time of their next FAA physical. This is a change in the previous FAA policy of having to report the surgery to the FAA and obtaining written clearance prior to flying. Controllers are advised to discuss the procedure with the Region Flight Surgeon (RFS) prior to surgery, and will require specific clearance from the RFS before returning to controlling. Typically controllers are given Special Consideration with follow up required at 6 months, and then can be returned to general eligibility.”
- Then again, nobody follows these rules anyway; I was told by a doctor the FAA believes less than 10% of pilots who’ve had a Lasic surgery performed had actually notified them.
Ps. Not me, still considering having the surgery done
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