Home › Device types › MLZ
Vitrectomy, Instrument Cutter
FDA product code MLZ · Class 2 · Ophthalmic
42
Registered devices
895
Adverse events
4
Recalls
4
510(k) clearances
Devices with this code
CONSTELLATION HYPERVIT ENGAUGE — Alcon Laboratories, Inc.CONSTELLATION® HYPERVIT® ENGAUGE® — Alcon Laboratories, Inc.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.ACS — AMERICAN CONTRACT SYSTEMS, INC.UNITY — Alcon Laboratories, Inc.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.UNITY — Alcon Laboratories, Inc.CONSTELLATION® HYPERVIT® TOTAL PLUS® — Alcon Laboratories, Inc.CONSTELLATION® ULTRAVIT® ENGAUGE® — Alcon Laboratories, Inc.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.UNITY — Alcon Laboratories, Inc.CONSTELLATION ULTRAVIT ENGAUGE — Alcon Laboratories, Inc.DISPOSABLE 23GA VITRECTOMY CUTTER — JOHNSON & JOHNSON SURGICAL VISION, INC.DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI — JOHNSON & JOHNSON SURGICAL VISION, INC.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.Alcon — Alcon Laboratories, Inc.CONSTELLATION® HYPERVIT® ENGAUGE® — Alcon Laboratories, Inc.DISPOSABLE 25GA VITRECTOMY CUTTER — JOHNSON & JOHNSON SURGICAL VISION, INC.CONSTELLATION® ULTRAVIT® ENGAUGE® — Alcon Laboratories, Inc.Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT — Alcon Laboratories, Inc.UNITY — Alcon Laboratories, Inc.CONSTELLATION® HYPERVIT® TOTAL PLUS® — Alcon Laboratories, Inc.Alcon — Alcon Laboratories, Inc.UNITY — Alcon Laboratories, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-05 | Alcon Research LLC | Due to incomplete seals in the pouch which provide the sterile barrier. |
| 2025-04-28 | Alcon Research LLC | Due 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 |
| 2018-09-24 | Johnson & Johnson Surgical Vision Inc | Packaging 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 |
| 2017-03-30 | Abbott 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.