FDA Medical Device Recalls (openFDA)
Gulden Ophthalmics: Venus Eye Sphere 20 mm (Sterile)
- Recall number
- Z-0532-03
- Recalling firm
- Gulden Ophthalmics
- Product
- Venus Eye Sphere 20 mm (Sterile)
- Status
- Terminated
- Initiated
- 2002-11-29
- Posted
- 2003-02-05
- Terminated
- 2004-02-06
- Reason
- lack of sterility assurance
- Root cause
- Other
- Action
- The recalling firm issued letters to the accounts requesting the return of the devices.
- Quantity
- not on file
- Distribution
- Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
- Lot, serial or model codes
- model number 14155. lot number 8404
- 510(k) numbers
- ["K972661"]
- PMA numbers
- not on file
- Product code
- HQX
- Firm FEI
- 2518410
- Firm city
- Elkins Park
- Firm state
- PA
- 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