Surgical Eye Tray
Ophthalmic · 21 CFR 886.4350
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
4 adverse event reports on file
- BVI CUSTOMEYES KITNov 9, 2022MalfunctionBeaver-visitec International, Inc15759230
- CUSTOMEYESDec 2, 2021InjuryBeaver Visitec International Limited3002808441-2021-00009
- CUSTOMEYESNov 18, 2021MalfunctionBeaver Visitec International Limited3002808441-2021-00008
- SURGICAL EYE TRAYAug 29, 2018InjuryMedline Industries Inc.1417592-2018-00083
Event type breakdown
Most-reported manufacturers
Recalls
6 recall events for this product code
- Beaver Visitec International, Inc.Open, ClassifiedUnknown
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery.
Kit packaging may have small holes compromising product sterility
Z-0405-2022 · View FDA record ↗ - Beaver Visitec International, Inc.Open, ClassifiedUnknown
Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery.
Kit packaging may have small holes compromising product sterility
Z-0406-2022 · View FDA record ↗ - Beaver Visitec International, Inc.Open, ClassifiedUnknown
Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery.
Kit packaging may have small holes compromising product sterility
Z-0407-2022 · View FDA record ↗ - Beaver Visitec International, Inc.Open, ClassifiedUnknown
Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery.
Kit packaging may have small holes compromising product sterility
Z-0408-2022 · View FDA record ↗ - Beaver Visitec International, Inc.Open, ClassifiedUnknown
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery.
Kit packaging may have small holes compromising product sterility
Z-0409-2022 · View FDA record ↗ - Beaver Visitec International, Inc.Open, ClassifiedUnknown
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery.
Kit packaging may have small holes compromising product sterility
Z-0410-2022 · View FDA record ↗
Registered firms
30 firms currently registered for this product code
Microspecialties Llc
Middletown, CT, US
Alcon Vision, Llc
Elkridge, MD, US
Oasis Medical, Inc.
GLENDORA, CA, US
Oasis Medical, Inc.
Glendora, CA, US
Zien Medical Technologies Llc
Salt Lake City, UT, US
Beaver-visitec International, Ltd
BIDFORD-ON-AVON Warwickshire, GB
Cardinal Health 200, Llc
El Paso, TX, US
Isomedix Operations Inc
El Paso, TX, US
Rio Bravo International Inc
El Paso, TX, US
Isomedix Operations Inc.
GRAND PRAIRIE, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Gri Medical & Electronic Technology Co., Ltd.
JIAXING Zhejiang, CN
Cardinal Health 200, Llc
Waukegan, IL, US
Hasa Optix
Brussels Brussels-Capital Region, BE
Beaver-visitec International, Inc.
Ciudad Juarez Chihuahua, MX
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Grupo American Industries, S.a. De C.v
Ciudad Juarez Chihuahua, MX
Alcon Research, Llc
Fort Worth, TX, US
Beaver-visitec International, Inc.
Waltham, MA, US
Hubei Lanbin Medical Group Co., Ltd.
Xiaogan City Hubei, CN
Katena Products, Inc.
Randolph, NJ, US
Alcon Research, Llc
Houston, TX, US
Blink Medical Ltd
Solihull, GB
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sterigenics U.s., Llc
Charlotte, NC, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.