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FDA Medical Device Recalls (openFDA)

Staar Surgical Co Inc: STAAR Phaco Tubing Kit

Recall number
Z-0775-05
Recalling firm
Staar Surgical Co Inc
Product
STAAR Phaco Tubing Kit
Status
Terminated
Initiated
2005-03-28
Posted
2005-04-27
Terminated
2005-07-11
Reason
Complaints of leaking with question of sterility and risk of infection in eye.
Root cause
Other
Action
Recall was conducted by telephone and letter delivered by FEDEX on April 7, 2004. All consignees have been contacted.
Quantity
114
Distribution
CA, NV, UT, FL, OR.
Lot, serial or model codes
Lot 08345
510(k) numbers
not on file
PMA numbers
not on file
Product code
GDY
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

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

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