LASIK Software Recalled After Unexpected Results

For eye doctors and their patients this has been a wild year for recalls. First, two different brands of contact lens solutions were yanked off shelves due to concerns about serious corneal infections.

Now the FDA has told the manufacturer of a laser refractive surgical device that its results are unacceptable. This latest Class 1 recall involves the software, an algorithm, used by the LADAR6000 lasers made by Alcon.

The LADAR6000 is used to correct myopia with and without astigmatism. The algorithm uses specific information about the patient's eye measurements and quickly compares that data to thousands of previous surgeries in order to calculate the precise laser treatment to be applied. This specific algorithm left patients with inaccurate outcomes - some unfixable with additional surgery.

According to the FDA, Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that, should this particular malfunction occur, use of the affected product may cause serious injury or death if the problem is not corrected.

The LADAR6000 manufacturer reports that all USA units have been shut down until this problem is fixed

Concerned consumers can call 1-877-523-2784 for additional information.

Related Topics:

• Implantable Contacts: Hope for Extreme Myopia
• WebMD Video: Computerized Scalpel for Steadier Eye Surgery

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