Eye Tray
FDA product code OJK · Class II (moderate risk) · 21 CFR 886.4790 · Ophthalmic
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.
0510(k) clearances
0PMA approvals
73recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3210-2026 | Convenience kits CATARACT PACK DYNJ59881AKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not… | Medline Industries, LP | 07/31/2026Open, Classified |
| Z-3078-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-2949-2026 Class II | Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-3061-2026 Class II | Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number:…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-2547-2026 Class II | Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922AThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | Medline Industries, LP | 05/21/2026Open, Classified |
| Z-2763-2026 Class II | Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.Incorrect concentration of Betadine solution contained within certain AVID convenience kits. | AVID Medical, Inc. | 05/07/2026Open, Classified |
| Z-2507-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | Medline Industries, LP | 05/04/2026Open, Classified |
| Z-2435-2026 Class II | Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053KKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, Classified |
| Z-2260-2026 Class II | Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627PSpecific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile.… | Medline Industries, LP | 04/10/2026Open, Classified |
| Z-2037-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | Medline Industries, LP | 03/19/2026Open, Classified |
| Z-1886-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1729-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-2113-2026 Class II | Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1420-2026 Class II | Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-0510-2026 Class II | MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals. | Medline Industries, LP | 10/03/2025Open, Classified |
| Z-0529-2026 Class II | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | Medline Industries, LP | 09/30/2025Open, Classified |
| Z-0185-2026 Class II | Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | American Contract Systems Inc. | 09/04/2025Open, Classified |
| Z-2045-2025 Class II | Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x…Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard… | MEDLINE INDUSTRIES, LP - Northfield | 05/23/2025Open, Classified |
| Z-1713-2025 Class II | Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183KIt was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… | MEDLINE INDUSTRIES, LP - Northfield | 03/19/2025Open, Classified |
| Z-1617-2025 Class II | Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | MEDLINE INDUSTRIES, LP - Northfield | 03/03/2025Open, Classified |
| Z-1451-2025 Class II | Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 02/11/2025Open, Classified |
| Z-1394-2025 Class II | Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLCMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 02/11/2025Open, Classified |
| Z-1136-2025 Class II | Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Cardinal Health 200, LLC | 11/08/2024Open, Classified |
| Z-0917-2025 Class II | Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2)…Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Cardinal Health 200, LLC | 11/08/2024Open, Classified |
| Z-0490-2025 Class III | a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11…Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to… | Alcon Research LLC | 10/15/2024Open, Classified |
| Z-0648-2025 Class II | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |
| Z-0180-2025 Class II | Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-0178-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-3120-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB…XXX | MEDLINE INDUSTRIES, LP - Northfield | 06/27/2024Open, Classified |
| Z-2522-2024 Class II | American Contract Systems Cataract Pack convenience kitProduct released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | American Contract Systems, Inc. | 05/06/2024Open, Classified |
| Z-3051-2024 Class II | Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2764-2024 Class II | Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-0832-2024 Class II | Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | American Contract Systems, Inc. | 11/29/2023Open, Classified |
| Z-1126-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | MEDLINE INDUSTRIES, LP - Northfield | 11/15/2023Open, Classified |
| Z-2190-2023 Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | MEDLINE INDUSTRIES, LP - Northfield | 05/18/2023Open, Classified |
| Z-2337-2023 Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | MEDLINE INDUSTRIES, LP - Northfield | 05/15/2023Open, Classified |
| Z-1095-2023 Class II | Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-0316-2023 Class II | regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | ROi CPS LLC | 10/20/2022Terminated |
| Z-0315-2023 Class II | regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | ROi CPS LLC | 10/20/2022Terminated |
| Z-0306-2023 Class II | regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | ROi CPS LLC | 10/20/2022Terminated |
| Z-0301-2023 Class II | regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | ROi CPS LLC | 10/20/2022Terminated |
| Z-0300-2023 Class II | regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | ROi CPS LLC | 10/20/2022Terminated |
| Z-0290-2023 Class II | regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kitSurgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | ROi CPS LLC | 10/20/2022Terminated |
| Z-0161-2023 Class II | BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings… | MEDLINE INDUSTRIES, LP - Northfield | 09/30/2022Open, Classified |
| Z-0160-2023 Class II | BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings… | MEDLINE INDUSTRIES, LP - Northfield | 09/30/2022Open, Classified |
| Z-0158-2023 Class II | BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings… | MEDLINE INDUSTRIES, LP - Northfield | 09/30/2022Open, Classified |
| Z-0157-2023 Class II | BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical…Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings… | MEDLINE INDUSTRIES, LP - Northfield | 09/30/2022Open, Classified |
| Z-0156-2023 Class II | BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings… | MEDLINE INDUSTRIES, LP - Northfield | 09/30/2022Open, Classified |
| Z-1705-2022 Class II | Various eye packs, cataract packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | American Contract Systems, Inc. | 06/16/2022Open, Classified |
| Z-0230-2022 Class II | bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent…Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades | Beaver Visitec International, Inc. | 10/08/2021Open, Classified |