Lasik (or Eyeglasses) Looking Better All the Time: Manufacturing Issues Not Responsible for Contact Solution Recall

May 29, 2007
I'd missed this little item, but last October, in the Archives of Opthalmology, a study was published confirming that LASIK surgery is safer than contact lens use.  Complications from the surgery occur in 1 out of 10,000 patient, the study said, where sight-threatening infections from contacts occur in 1 in 2,000.  LASIK advocates couldn't have hoped for better promotion than the news that came from FDA this morning, announcing that  Advanced Medical Optics had voluntarily recalled its Complete Moisture Plus contact lens solution after the Centers for Disease Control published a report (access summary here) suggesting that the cleanser might be reponsible for some cases of Acanthamoeba Keratitis.  This relatively rare condition, like its counterpart, Fusarium Keratitis, is on the rise, and has been linked to multipurpose cleaners, and improper soft contact lens cleaning.  The company has responded by saying that no manufacturing problems were at play.  Below, its statement as reported by The Boston Herald (for full article, click here).
"What we're trying to handle right now ... is what the CDC hit us with," as James Mazzo, president and chief executive officer of Santa Ana, Calif.-based Advanced Medical Optics Inc., was quoted in the Herald article. As you may recall, Bausch & Lomb had recalled its ReNu cleanser last Spring, after receiving a Warning Letter from FDA citing manufacturing issues at its facility. This initiated CAPAs and, as of last Fall, the company said it had resolved most of those issues; presumably they've been addressed by now.
I'd missed this little item, but last October, in the Archives of Opthalmology, a study was published confirming that LASIK surgery is safer than contact lens use.  Complications from the surgery occur in 1 out of 10,000 patient, the study said, where sight-threatening infections from contacts occur in 1 in 2,000.  LASIK advocates couldn't have hoped for better promotion than the news that came from FDA this morning, announcing that  Advanced Medical Optics had voluntarily recalled its Complete Moisture Plus contact lens solution after the Centers for Disease Control published a report (access summary here) suggesting that the cleanser might be reponsible for some cases of Acanthamoeba Keratitis.  This relatively rare condition, like its counterpart, Fusarium Keratitis, is on the rise, and has been linked to multipurpose cleaners, and improper soft contact lens cleaning.  The company has responded by saying that no manufacturing problems were at play.  Below, its statement as reported by The Boston Herald (for full article, click here). "What we're trying to handle right now ... is what the CDC hit us with," as James Mazzo, president and chief executive officer of Santa Ana, Calif.-based Advanced Medical Optics Inc., was quoted in the Herald article. As you may recall, Bausch & Lomb had recalled its ReNu cleanser last Spring, after receiving a Warning Letter from FDA citing manufacturing issues at its facility. This initiated CAPAs and, as of last Fall, the company said it had resolved most of those issues; presumably they've been addressed by now.
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