The Recall Desk
ModerateFDA (Devices)·Z-0581-2026·Announced 2025-12-03

Vitrectomy probe packs recalled with no reason stated in the record

Alcon Research is recalling 28,323 Constellation UltraVit 10K and HyperVit 20K vitrectomy probe packs; the enforcement record does not state a reason.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the enforcement record states no reason, defect or health consequence for this action and reports no injuries.

Plain-English summary

Constellation UltraVit 10K and Constellation HyperVit 20K products from Alcon Research are being recalled, covering references including 8065000093, 8065000095 and 8065000096, the 25+ and 27+ TotalPlus CP packs, and 23GA bevel UltraVit items.

The reason field in this enforcement record contains a truncated block of packaging metadata and product identifiers, and no statement of why the recall was initiated. This summary therefore does not describe a defect, hazard or consequence, because the record does not provide one.

The recall covers 28,323 units. Distribution was worldwide, including nationwide in the United States and in Pennsylvania, Minnesota, California, Florida, Louisiana, Colorado, Kansas, Illinois, Alaska, Ohio and New York. The FDA has classified the action as Class II.

Facilities holding affected product should contact Alcon Research for the recall details and instructions.

The recalled product

Product
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ B
Manufacturer
Alcon Research LLC
Category
Medical Device — Surgical accessory
Hazard
Affected units
28,323

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)

  • UDI-DI/REF: 5414660389996/C26992-01
  • 5414660396666/C23069-05
  • 5414660396697/C23125-04
  • 5414660400332/C17655-06
  • 5414660400356/C17731-06
  • 5414660401254/C27454-02
  • 5414660401285/C27450-02
  • 5414660401292/C27449-02
  • 5414660405221/C27453-03
  • 5414660409380/C27818-04
  • 5414660409700/C27864-01 5414660410225/C27876-01
  • 5414660413356/C28044-05
  • 5414660413691/C19139-07
  • 5414660417668/C25243-02
  • 5414660418221/C27440-02
  • 5414660418238/C27441-03
  • 5414660418245/C27442-02
  • 5414660418252/C27443-02
  • 5414660418269/C27444-02
  • 5414660418276/C27445-02

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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