Reported Aug 23, 2023 · Ongoing
Phaco Standalone Tips
Alcon Research, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research, LTD. · 714 Columbia Ave · Sinking Spring, PA · 19608-1405
Is this the product you have?
- Phaco Standalone Tips
- Lot codes and dates
Catalog No. 30KTS30RTS806574080680657408378065750261806575026380657502648065750852806575085380657511768065751177806575117880657520658065752066806579002080657900228065790023Product Code 100000692100000691100002823100002787100058543100004407100004408100006953100006952100006224100006225100006226100009104100009105100000696100000698100000708
- UDI-DI
364 of 364 codes
380657403042380657403028380657408061380657408375380657502615380657502639380657502646380657508525380657508532380657511761380657511778380657511785380657520657380657520664380657900206380657900220380657900237Lots 152A2F14T8U814V9D714WN7D14WNFC14YJJD15118L15KCLD14DNN314XP2V154DY2155L1M155LD115EM4L15FU4D14HA1214LH5X14LHL414N03H14N0A614PLY214PM6Y14T8UF14T95K14UL3F14UY8J14V94T14V9DD14YJ8N14YJJN15075D1511AL155LD315AYD115AYD315AYD414C5L114V8YF1510VH153KHX15AYF715AYF815CP8C
- Amount recalled
- 444,372 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
This product could cause temporary or reversible health problems — stop using it.
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