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FDA Medical Device Recalls (openFDA)

Staar Surgical Co Inc: MicroSTAAR Injector, MSI-PF Packed ten per box.

Recall number
Z-0957-04
Recalling firm
Staar Surgical Co Inc
Product
MicroSTAAR Injector, MSI-PF Packed ten per box.
Status
Terminated
Initiated
2004-04-21
Posted
2004-07-20
Terminated
2012-07-26
Reason
Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.
Root cause
Other
Action
Recall will be implemented by visits by company representatives.
Quantity
124 boxes, 10 per box.
Distribution
Nationwide
Lot, serial or model codes
Lot 1186591 Expires 12/31/06 Lot 1186692 Expires 12/31/06
510(k) numbers
["K980696"]
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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