FDA Issues Class I Recall on CooperVision Avaira Toric Soft Contact Lenses
/EINPresswire.com/ Ennis & Ennis, P.A. Explains the Recent Recall and Outlines the Recommendations to Patients Affected
On October 14, 2011, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall of CooperVision's AVAIRA Toric Soft Contact Lenses due to an unintended presence of silicone oil residue, which can cause hazy or blurry vision, discomfort to the eye and injuries requiring medical treatment.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm275835.htm. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The lenses, which are indicated for single-use disposable wear and daily wear, are used for the correction of nearsightedness or farsightedness with astigmatism in persons who may or may not have had their natural lens of their eye removed and who has not had previous eye diseases with a lens powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
CooperVision first notified distributors of the recall on August 19, 2011, however, the FDA posted the recent recall notice after reporting that a larger effort was needed to alert consumers to the defective product.
Consumers can visit CooperVison's website at www.coopervision.com/recall and enter the lot number of their package to determine whether their lenses are part of the recall. The affected lenses were manufactured from November 1, 2010 through August 3, 2011. Approximately 778,301 lenses were distributed.
Ennis & Ennis, P.A. recommends consumers who have the affected lenses, but have not suffered the symptoms, should return their lenses to their eye care practitioner or point of purchase.
Furthermore, consumers who have been affected by the recall and have suffered symptoms should immediately stop wearing the lenses and immediately contact their eye care practitioner for advice. Then they should file an adverse event report with the FDA at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Lastly, they should consult with an experienced attorney.
Ennis & Ennis is offering free, nationwide, confidential consultations to anyone who has suffered an eye injury as a result of the AVAIRA Toric contact lenses by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies as well as medical device makers.
Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.
Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin, Ocella Birth Control Pills, and Transvaginal Mesh Devices.
Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit www.ennislaw.com.
Media Contact:
Jami Angelini Haggerty
Ennis & Ennis, P.A.
(954) 543-4452
www.ennislaw.com
PR courtesy of Online PR Media: http://bit.ly/rjwbE5
On October 14, 2011, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall of CooperVision's AVAIRA Toric Soft Contact Lenses due to an unintended presence of silicone oil residue, which can cause hazy or blurry vision, discomfort to the eye and injuries requiring medical treatment.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm275835.htm. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The lenses, which are indicated for single-use disposable wear and daily wear, are used for the correction of nearsightedness or farsightedness with astigmatism in persons who may or may not have had their natural lens of their eye removed and who has not had previous eye diseases with a lens powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
CooperVision first notified distributors of the recall on August 19, 2011, however, the FDA posted the recent recall notice after reporting that a larger effort was needed to alert consumers to the defective product.
Consumers can visit CooperVison's website at www.coopervision.com/recall and enter the lot number of their package to determine whether their lenses are part of the recall. The affected lenses were manufactured from November 1, 2010 through August 3, 2011. Approximately 778,301 lenses were distributed.
Ennis & Ennis, P.A. recommends consumers who have the affected lenses, but have not suffered the symptoms, should return their lenses to their eye care practitioner or point of purchase.
Furthermore, consumers who have been affected by the recall and have suffered symptoms should immediately stop wearing the lenses and immediately contact their eye care practitioner for advice. Then they should file an adverse event report with the FDA at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Lastly, they should consult with an experienced attorney.
Ennis & Ennis is offering free, nationwide, confidential consultations to anyone who has suffered an eye injury as a result of the AVAIRA Toric contact lenses by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies as well as medical device makers.
Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.
Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin, Ocella Birth Control Pills, and Transvaginal Mesh Devices.
Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit www.ennislaw.com.
Media Contact:
Jami Angelini Haggerty
Ennis & Ennis, P.A.
(954) 543-4452
www.ennislaw.com
PR courtesy of Online PR Media: http://bit.ly/rjwbE5
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