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Sign in to claim this brandHAAG-STREIT USA, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 3535 Kings Mills Rd, MASON, OH, 45040
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000136533
- DUNS Number
- —
Catalogue (51)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Haag-Streit Contact Glasses Stery Cup, Accessory | K051103 | FDA 510(k) | Class II | Active |
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FDA Recalls (12)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 3, 2021 | Z-0477-2022 | — | open, classified | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off |
| Nov 3, 2021 | Z-0478-2022 | — | open, classified | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off |
| Apr 15, 2021 | Z-1560-2021 | — | open, classified | Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI). |
| Nov 20, 2020 | Z-0697-2021 | — | open, classified | Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye |
| Jul 31, 2019 | Z-2483-2019 | — | terminated | software error in the central control unit of the floor stand. |
| Jul 31, 2019 | Z-2482-2019 | — | terminated | software error in the central control unit of the floor stand. |
| Jul 31, 2019 | Z-2484-2019 | — | terminated | software error in the central control unit of the floor stand. |
| Jan 5, 2017 | Z-1500-2017 | — | terminated | There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow. |
| Aug 17, 2012 | Z-2411-2012 | — | terminated | The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101. |
| Nov 14, 2011 | Z-0638-2012 | — | terminated | Currently there is a possibility, at the start of the perimetry examination, for the background illumination of the cupola not to turn on. If no illumination of cupola occurs, data obtained from the examination could provide the doctor with results that would appear to be better than actual. |
| Jun 20, 2011 | Z-2964-2011 | — | terminated | A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000. |
| May 19, 2010 | Z-1897-2010 | — | terminated | 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 |