FDA Medical Device Recalls (openFDA)
OCULOGICA: EyeBOX Model OCL 02
- Recall number
- Z-2398-2019
- Recalling firm
- OCULOGICA
- Product
- EyeBOX Model OCL 02
- Status
- Terminated
- Initiated
- 2019-04-16
- Posted
- not on file
- Terminated
- 2020-04-10
- Reason
- A review of the user manual revealed that two precaution statements were missing.
- Root cause
- Labeling design
- Action
- IMPORTANT: Warnings and Precautions Correction for the EyeBOX emails were sent to customers on 4/16/19.
- Quantity
- 3
- Distribution
- The products were distributed to the following US states: MD and NY
- Lot, serial or model codes
- Serial Numbers TT003, TT004, TT005
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QEA
- Firm FEI
- 3014535677
- Firm city
- New York
- Firm state
- NY
- 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