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Vitrectomy, Instrument Cutter

FDA product code MLZ · Class 2 · Ophthalmic

42
Registered devices
908
Adverse events
4
Recalls
4
510(k) clearances

Devices with this code

CONSTELLATION ULTRAVIT ENGAUGE — Alcon Laboratories, Inc.CONSTELLATION HYPERVIT ENGAUGE — Alcon Laboratories, Inc.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.CONSTELLATION® HYPERVIT® ENGAUGE® — Alcon Laboratories, Inc.DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI — JOHNSON & JOHNSON SURGICAL VISION, INC.UNITY — Alcon Laboratories, Inc.Alcon — Alcon Laboratories, Inc.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.MICOR Vitrector — Carl Zeiss Meditec, Cataract Technology, Inc.ACS — AMERICAN CONTRACT SYSTEMS, INC.CONSTELLATION® HYPERVIT® TOTAL PLUS® — Alcon Laboratories, Inc.CONSTELLATION® ULTRAVIT® ENGAUGE® — Alcon Laboratories, Inc.CONSTELLATION® HYPERVIT® TOTAL PLUS® — Alcon Laboratories, Inc.CONSTELLATION HYPERVIT ENGAUGE — Alcon Laboratories, Inc.MICOR Auto I/A — Carl Zeiss Meditec, Cataract Technology, Inc.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.CONSTELLATION® HYPERVIT® TOTAL PLUS® — Alcon Laboratories, Inc.UNITY — Alcon Laboratories, Inc.CONSTELLATION® ULTRAVIT® ENGAUGE® — Alcon Laboratories, Inc.DISPOSABLE 25GA VITRECTOMY CUTTER — JOHNSON & JOHNSON SURGICAL VISION, INC.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.CONSTELLATION® HYPERVIT® ENGAUGE® — Alcon Laboratories, Inc.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.

Recent recalls

DateFirmReason
2025-08-05Alcon Research LLCDue to incomplete seals in the pouch which provide the sterile barrier.
2025-04-28Alcon Research LLCDue to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the liddi
2018-09-24Johnson & Johnson Surgical Vision IncPackaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the nee
2017-03-30Abbott Medical Optics Inc. (AMO)Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.