Recall Z-1897-2010 ยท HLF Device, Measuring, Lens Radius, Ophthalmic
Haag-Streit USA Inc
Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland. Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of Intraocular Lens for implantation after removal of the natural crystalline lens following cataract removal.
| Date | Jun 24, 2010 (initiated May 19, 2010) |
| Status | Terminated |
| Reason | During the creation of the Lenstar LS 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for US distribution. The current software installed allows the user to manually alter the retinal thickness measurement, which could modify the automatic axial eye length measurement resulting in the selection of an incorrect in |
| Root cause | PMA |
| Action | HAAG - Streit USA, Inc. issued notification letters to their customers informing them of the problem. They instructed their customer to refrain from adjusting the gates for the measurement of retinal thickness until after the system has been updated. For further information, contact HAAG - Streit USA, Inc. at 1-513-336-7255. |
| Quantity | 45 units |
| Distribution | Nationwide Distribution -- Including AL, AZ, CA, FL, ID, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, VA, VT, WA and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082891 | LENSTAR, MODEL LS900 Haag-Streit AG, Oct 20, 2009 |