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. 30KTS
    • 30RTS
    • 8065740806
    • 8065740837
    • 8065750261
    • 8065750263
    • 8065750264
    • 8065750852
    • 8065750853
    • 8065751176
    • 8065751177
    • 8065751178
    • 8065752065
    • 8065752066
    • 8065790020
    • 8065790022
    • 8065790023
    • Product Code 100000692
    • 100000691
    • 100002823
    • 100002787
    • 100058543
    • 100004407
    • 100004408
    • 100006953
    • 100006952
    • 100006224
    • 100006225
    • 100006226
    • 100009104
    • 100009105
    • 100000696
    • 100000698
    • 100000708
  • UDI-DI

    364 of 364 codes

    • 380657403042
    • 380657403028
    • 380657408061
    • 380657408375
    • 380657502615
    • 380657502639
    • 380657502646
    • 380657508525
    • 380657508532
    • 380657511761
    • 380657511778
    • 380657511785
    • 380657520657
    • 380657520664
    • 380657900206
    • 380657900220
    • 380657900237
    • Lots 152A2F
    • 14T8U8
    • 14V9D7
    • 14WN7D
    • 14WNFC
    • 14YJJD
    • 15118L
    • 15KCLD
    • 14DNN3
    • 14XP2V
    • 154DY2
    • 155L1M
    • 155LD1
    • 15EM4L
    • 15FU4D
    • 14HA12
    • 14LH5X
    • 14LHL4
    • 14N03H
    • 14N0A6
    • 14PLY2
    • 14PM6Y
    • 14T8UF
    • 14T95K
    • 14UL3F
    • 14UY8J
    • 14V94T
    • 14V9DD
    • 14YJ8N
    • 14YJJN
    • 15075D
    • 1511AL
    • 155LD3
    • 15AYD1
    • 15AYD3
    • 15AYD4
    • 14C5L1
    • 14V8YF
    • 1510VH
    • 153KHX
    • 15AYF7
    • 15AYF8
    • 15CP8C
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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.