Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Haag-Streit GroupLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Haag-Streit USA with 9 device recalls and 1 510(k) clearance. The most recent is a device recall dated Nov 3, 2021: OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 3, 2021 | OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4Class II · Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely swit | Device recalls |
| Nov 3, 2021 | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4Class II · Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely swit | Device recalls |
| Apr 15, 2021 | Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.Class II · Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast | Device recalls |
| Nov 20, 2020 | Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Class II · Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button | Device recalls |
| Jul 31, 2019 | HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible thrClass II · software error in the central control unit of the floor stand. | Device recalls |
| Jul 31, 2019 | HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible throughClass II · software error in the central control unit of the floor stand. | Device recalls |
| Jul 31, 2019 | HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible throughClass II · software error in the central control unit of the floor stand. | Device recalls |
| Jan 5, 2017 | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).Class II · There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workfl | Device recalls |
| Jun 7, 2005 | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYK051103 · HJK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
