Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland. Used for obtaining ocular measurement
FDA device recall Z-1897-2010 · posted 2010-06-24 · Terminated
Recall details
- Recalling firm
- Haag-Streit USA Inc
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- PMA
- Status
- Terminated
- Product code
- HLF
- Quantity affected
- 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.
- Date initiated
- 2010-05-19
- Date posted
- 2010-06-24
- Date terminated
- 2012-02-24
- Location
- Mason, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LENSTAR, MODEL LS900 (K082891) | Haag-Streit AG | 2009-10-20 |