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FDA Medical Device Recalls (openFDA)

Staar Surgical Co Inc: MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF

Recall number
Z-0766-04
Recalling firm
Staar Surgical Co Inc
Product
MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF
Status
Terminated
Initiated
2004-02-23
Posted
2004-07-20
Terminated
2005-01-04
Reason
Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
Root cause
Other
Action
Firm will be sending thier representatives to customers to inspect inventory and arrange return of product.
Quantity
690 injectors
Distribution
Nationwide.
Lot, serial or model codes
Lot 11853090.   Sterility Date : 11/18/2003 Expiration Date: 10/31/2006
510(k) numbers
not on file
PMA numbers
not on file
Product code
KYB
Firm FEI
2023826
Firm city
Monrovia
Firm state
CA
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

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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

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