The Recall Desk
HighFDA (Devices)·Z-0409-2022·Announced 2021-12-29

Malosa Core SMILE Pack Medical Refractive Kit Recalled for Packaging Defect

Beaver Visitec International is recalling the Malosa Core SMILE Pack 1-Medical Refractive Kit because packaging may contain small holes that compromise sterility. The recall affects 680 units distributed in nine states.

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: This is an FDA Class II medical device recall for a surgical kit with potential sterility compromise due to packaging defects. No deaths, hospitalizations, or reported injuries have occurred. Per the rubric, risk-of-harm medical products where injury has not yet been reported score 3 (High).

Plain-English summary

Beaver Visitec International, Inc. is recalling the Malosa Core SMILE Pack 1-Medical Refractive Kit (Part Number: MMK884), a surgical instrument kit intended for use in cataract, corneal, and refractive eye surgery. The recall affects 680 units with 14 specific lot numbers.

The packaging may contain small holes that compromise the sterility of the kit contents. Sterile surgical instruments are critical for patient safety, and any breach in sterility can introduce contamination and increase the risk of infection.

The affected products were distributed to healthcare facilities in California, Colorado, Louisiana, Massachusetts, Maryland, North Dakota, Pennsylvania, Tennessee, and Utah. Healthcare providers should stop using any affected units immediately and contact Beaver Visitec International for further instructions.

Patients who may have been treated with instruments from the recalled lots should consult their healthcare provider regarding any potential concerns or follow-up evaluation.

The recalled product

Product
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Surgical Kit
Hazard
Affected units
680

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 (14)

  • Lot Numbers: 3261518
  • 3272335
  • 3278550
  • 3292632
  • 3305153
  • 3326272
  • 3331632
  • 3334880
  • 3344465
  • 3348295
  • 3350319
  • 3357568
  • 3362608
  • 3363639

Distribution

Distributed in 9 states:

Part of a larger recall action

This product is one of 6 recalled by Beaver Visitec International, Inc. 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 · Beaver Visitec International, Inc.

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Same hazard · sterility compromise

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