FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1897-2010
- Recalling firm
- Haag-Streit USA Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-05-19
- Posted
- 2010-06-24
- Terminated
- 2012-02-24
- 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.
- Lot, serial or model codes
- SERIAL Numbers: 223, 224, 225, 284, 285, 316, 317, 319, 320, 322, 323, 324, 325, 327, 330, 331, 332, 333, 364, 365, 366, 368, 369, 377, 378, 379, 381, 384, 385, 386, 405, 407, 408, 409, 411, 412, 413, 415, 416, 452, 454, 460, 461, 490 and 494.
- 510(k) numbers
- ["K082891"]
- PMA numbers
- not on file
- Product code
- HLF
- Firm FEI
- 1000136533
- Firm city
- Mason
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28