The Recall Desk
SevereFDA (Devices)·Z-2410-2023·Announced 2023-08-23

Phaco Standalone Tips Recalled Due to Plastic Debris Risk

Alcon is recalling 444,372 units of Phaco Standalone Tips worldwide because the plastic wrench included with the product can generate plastic debris when over-tightened, potentially injuring patients.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II medical device recall with documented reports of patient injury occurring during surgical procedures. Per the severity rubric, FDA Class II recalls with reported injury meet the criteria for Severe classification.

Plain-English summary

Alcon Research, LTD. is recalling 444,372 units of Phaco Standalone Tips. The product is distributed worldwide, including across the United States and in more than 100 countries.

The recall was issued due to reports of patient injury that have occurred during procedures involving the device. The injury risk results from the potential for plastic debris to be generated when the included plastic wrench is over-tightened during use.

This is an FDA Class II medical device recall. The FDA recall reference number is Z-2410-2023.

The recalled product

Product
Phaco Standalone Tips
Manufacturer
Alcon Research, LTD.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
444,372

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Catalog No. 30KTS
  • 30RTS
  • 8065740806
  • 8065740837
  • 8065750261
  • 8065750263
  • 8065750264
  • 8065750852
  • 8065750853
  • 8065751176
  • 8065751177
  • 8065751178
  • 8065752065
  • 8065752066
  • 8065790020
  • 8065790022
  • 8065790023
  • Product Code 100000692
  • 100000691
  • 100002823

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Alcon Research, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Alcon Research, LTD.

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Same hazard · plastic debris

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