RegWardenFDA facility compliance records
Company

HAAG-STREIT HOLDING

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

Recalls by year

FDA actions on record by year2012: 1 recalls; 2017: 1 recalls; 2019: 1 recalls; 2020: 1 recalls; 2021: 2 recalls1’12’13’14’15’161’17’181’191’202’21’22’23’24’25’26
  • Recalls (6)

Registered facilities (5)

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. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “HAAG-STREIT HOLDING — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8031066-haag-streit-holding/

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