FDA Medical Device Recalls (openFDA)
Haag-Streit USA Inc: Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
- Recall number
- Z-1560-2021
- Recalling firm
- Haag-Streit USA Inc
- Product
- Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
- Status
- Open, Classified
- Initiated
- 2021-04-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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).
- Root cause
- Software design
- Action
- On 04/06/2021, Haag-Streit issued an Urgent Medical Device Correction notice to their customer via letter notifying them Eyesuite 9.3.1 software may mix up examination data and patient name when printing or generating a PDF.
- Quantity
- not on file
- Distribution
- US Nationwide distribution in the state of WA.
- Lot, serial or model codes
- Software version 9.3.1
- 510(k) numbers
- ["K082891"]
- PMA numbers
- not on file
- Product code
- HJO
- 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