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PHACO TIP WRENCH
Carl Zeiss Meditec AG · Model 303060-0121-000 · UDI-DI 04049539100177
NKX
Prescription
5
510(k) clearances
12
Adverse events
11
Recalls
3
Facilities
Description
This re-usable device is an accessory for ZEISS phaco systems. It has been designed to screw and unscrew the tips to the phaco handpiece during human eye surgery.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2008-08-08 | Sterilmed Inc | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e |
| 2008-03-26 | Bausch & Lomb Inc | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| 2008-03-26 | Bausch & Lomb Inc | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| 2008-03-26 | Bausch & Lomb Inc | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| 2008-03-26 | Bausch & Lomb Inc | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| 2008-03-26 | Bausch & Lomb Inc | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| 2008-03-26 | Bausch & Lomb Inc | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| 2008-03-26 | Bausch & Lomb Inc | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| 2008-03-26 | Bausch & Lomb Inc | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.