The Recall Desk
HighFDA (Devices)·Z-1328-2021·Announced 2021-04-07

Alcon Custom Ophthalmic Surgical Procedure Packs Recalled for Mold

Alcon is recalling 249,853 custom ophthalmic surgical procedure packs because mold was found on gowns included in the packages.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a contamination hazard (mold) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the High severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Alcon Research, LLC is recalling 249,853 units of Alcon Custom Ophthalmic Surgical Procedure Packs. The recall was initiated after reports were received concerning mold found on gowns included in the custom ophthalmic surgery packages.

The affected products were distributed nationwide in the United States, including Puerto Rico, as well as in Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand. The recall covers a specific list of lot numbers and pack numbers, which are detailed in the official FDA recall record.

Healthcare facilities and consumers should stop using these specific surgical packs and contact Alcon Research, LLC for further instructions on how to return or dispose of the affected products.

The recalled product

Product
Alcon Custom Ophthalmic Surgical Procedure Packs
Manufacturer
Alcon Research, LLC
Category
Medical Device — Surgical Packs
Hazard
Affected units
249,853

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)

  • Lot Number Pak Number 2461031H 0012-61
  • 2461032H 0017-68
  • 2471522H 0017-69
  • 2470351H 0091-68
  • 2475039H 0091-69
  • 2477748H 0147-62
  • 2462158H 0148-63
  • 2460228H 0188-76
  • 2467978H 0204-58
  • 2462215H 0234-66
  • 2467189H 0234-66
  • 2469722H 0234-66
  • 2469576H 0235-74
  • 2471338H 0235-74
  • 2476349H 0235-74
  • 2456156H 0316-66
  • 2451430H 0365-74
  • 2464636H 0437-38
  • 2466614H 0437-38
  • 2469145H 0437-38

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

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