Home › Device types › KYG
Device, Irrigation, Ocular Surgery
FDA product code KYG · Class 1 · Ophthalmic
390
Registered devices
2,134
Adverse events
11
Recalls
40
510(k) clearances
Devices with this code
Ambler Surgical — AMBLER SURGICAL CORP.MST BL Blue Silicone Sleeve and MST plastic wrench — MICROSURGICAL TECHNOLOGY, INC.Dual Bore Cannula 25G, 36mm — AKTIVE SRLInfusion Handle — Medetz Surgical Instruments LLCAmbler Surgical — AMBLER SURGICAL CORP.Disposable Infusion Cannula, 4.0 mm, for silicone oil — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Ambler Surgical — AMBLER SURGICAL CORP.Ambler Surgical — AMBLER SURGICAL CORP.Ambler Surgical — AMBLER SURGICAL CORP.Ambler Surgical — AMBLER SURGICAL CORP.N/A — MICROVISION, INC.Ambler Surgical — AMBLER SURGICAL CORP.Set Bi-manual I/A Handpieces 23G — AKTIVE SRLFull Handle Backflush 20G Soft tip Extensible Active/Passive — AKTIVE SRLDual Bore Cannula 25G — AKTIVE SRLAmbler Surgical — AMBLER SURGICAL CORP.Ambler Surgical — AMBLER SURGICAL CORP.N.A. — Geuder AktiengesellschaftAmbler Surgical — AMBLER SURGICAL CORP.Ambler Surgical — AMBLER SURGICAL CORP.MSI Precision Specialty Instruments — Med Saver, Inc.Ambler Surgical — AMBLER SURGICAL CORP.MorTan — ZIEN MEDICAL TECHNOLOGIES, INC.Ambler Surgical — AMBLER SURGICAL CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-26 | B. Braun Medical, Inc. | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose bo |
| 2010-05-12 | Insight Instruments, Inc. | Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in 1.5 ml Syringe due to a potential weakness of the |
| 2010-05-12 | Insight Instruments, Inc. | Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in 1.5 ml Syringe due to a potential weakness of the |
| 2007-04-09 | Oasis Medical Inc | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. |
| 2007-04-09 | Oasis Medical Inc | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. |
| 2007-04-09 | Oasis Medical Inc | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. |
| 2007-03-02 | Becton Dickinson and Company | Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm) |
| 2005-08-24 | Oasis Medical Inc | "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative |
| 2005-08-24 | Oasis Medical Inc | "Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the |
| 2005-08-24 | Oasis Medical Inc | "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative |
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