Facility

HAAG-STREIT AG

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000176188
Establishment type	Manufacture Medical Device
Location	GARTENSTADTSTRASSE 10 KOENIZ Bern, CH CH-3098
Registration status	Active · expires 2026
Parent company	HAAG-STREIT HOLDING (owner-operator 8031066)
Brand names	Lenstar Myopia APS; EyeSuite Myopia Standalone; Eyesuite Myopia; EyeSuite Myopia + AMMC Software

Activity by year

Recalls (6)

Devices registered here (1)

Biomicroscope, Slit-Lamp, Ac-Powered
Product code HJO (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.1850

Recalls & enforcement

Class IIOngoing2021-11-03
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Class IIOngoing2021-04-15
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).
Class IIOngoing2020-11-20
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
Class IITerminated2019-07-31
software error in the central control unit of the floor stand.
Class IITerminated2017-01-05
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Class IITerminated2012-08-17
The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HAAG-STREIT AG (FEI 1000176188) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000176188-haag-streit-ag/

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