D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Illuminated Curved Laser probe Iris Retractor. Straight Laser Probe with Alcon adaptor Laser Probe, straight, with DORC connector Stepped Laserprobe, with Alcon connector Stepped Laserprobe, with DORC connector Laser Probe, curved, with DORC connector Curved Laser Probe with Alcon adaptor High flow viscous fluid extraction accessory Disposable Infusion Cannula Collection bag Disposable pack for viscous fluid extraction. DMEK Surgical Disposable Set Sterilization tray for 1 Micro-forceps/scissors. EVA NEXUS, Phaco vitrectomy system including laser with DORC connector EVA NEXUS Custom Phaco Pack 30 (Angled) Directional Laser Probe with Alcon / Lumenis connector EVA NEXUS cartridge with 0,5 L collection bag EVA NEXUS Irrigation and Aux. Aspiration Tubing EVA NEXUS, Phaco vitrectomy system EVA NEXUS Custom cartridge with 0,5 l collection bag EVA NEXUS Custom Phaco Pack 45 (Angled) 1cc syringe holder for micro-injection EVA NEXUS, Phaco vitrectomy system including laser with SMA connector EVA NEXUS Digital Overlay System EVA Nexus Infusion and Aux. Aspiration Tubing EVA NEXUS Custom Phaco Pack 45 (Straight) EVA Nexus Irrigation Tubing EVA NEXUS Custom Phaco Pack 30 (Straight) EVA Nexus Infusion Tubing EVA NEXUS Infusion Giving Set EVA NEXUS, Phaco emulsification system EVA NEXUS Combined TDC Pack EVA Nexus Aux. Aspiration Tubing Two Dimensional Cutter – 20k CPM Directional Laser Probe with DORC connector EVA NEXUS Posterior TDC Pack D.A.L.K. Spatula Dissection Set Eckardt Membrane Pic Disposable Microscissors: Hooked Extendible curved spatula P.L.K. Scraper Disposable ILM Micro Pick Needle DMEK Sinskey Hook Down Disposable reversed Sinskey hook with irrigation Disposable Eckardt Membrane Pic Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System. Shielded TotalView Endoillumination Probe, including illuminated scleral depressor TotalView Endoillumination Probe, including illuminated scleral depressor TotalView Chandelier for cannula system TotalView Endoillumination Probe, with 2 exchangeable tips Disposable Chandelier fiber (one fiber) with Photon connector and guidance needle Eckardt TwinLight Chandelier with Photon connector and guidance needle Spaide TotalView Endoillumination Probe, including illuminated scleral depressor TotalView Chandelier for Eckardt cannula system 27G Chandelier fiber and 23G standard D-style fiber optic handpiece incl. guidance needle. Extendible Light Probe Disposable Eckardt Twinlight Chandelier Endoillumination Probe, including illuminated scleral depressor Disposable Chandelier fiber (one fiber) incl. guidance needle EVA, combined machine EVA, anterior machine EVA, combined machine including Laser (SMA connector) EVA, combined machine including Laser (DORC connector) Closure valves for cannula system. Cannula set with High Flow infusion line. One step stiletto insertor Disposable one step single cannula including inserter Single Trocar Disposable Universal silicone infusion line for cannula system. Two Step Cannula set with High Flow infusion line. Reusable Two step cannula system Disposable Two step vitrectomy system High Flow infusion line Disposable Hybrid Trocar System Disposable One step Cannula System 27G Ultra Short Disposable One-Step cannula system Reusable universal cannula Disposable Keratoscope. Reusable bipolar cord Charles Flute instrument. Backflush instrument with brush needle Eckardt Backflush Handpiece with luer lock Replacement Backflush Needle with silicone tip, straight. Large replacement backflush Reservoir Backflush Instrument with blunt needle Replacement backflush needle, straight Kusaka Scleral Depressor. Eckardt Pressure Plate Disposable Vitrectomy Lens Helsinki Hydrodissector (Curved) Korobelnik self-retaining infusion cannula Backflush Instrument with soft-tip cannula and active aspiration LASIK Irrigating Cannula, 2 Ports soft tipped cannulas Disposable High Myopic Backflush instrument, with brush needle and active aspiration Disposable Replacement backflush brush Needles Replacement backflush reservoir with active aspiration. Disposable viscous fluid injection / extraction cannula Disposable Backflush instrument, with extended silicone tip and active aspiration Cystotome (Short Curve) Formed Irr. Capsularhexis Disposable heavy silicon extraction cannula Disposable Backflush instrument, with brush needle and active aspiration Disposable Viscous Fluid Extraction cannula Disposable Shiraga Backflush instrument, with extendible brush tip and active aspiration Anaesthetic Cannula, Retrobulbar – Atkinson Disposable Backflush instrument, with blunt needle and passive aspiration Lachrymal Cannula (Curved) Disposable Dual Bore PFC Cannula Replacement tubing for VFI Self Retaining Anterior Chamber Maintainer (Lewicky) Infusion line for infusion cannula I/A Cannula (Standard) 0.3mm port (Simcoe) Disposable Replacement backflush reservoirs. Cortex Extractor, 0.3mm Top port Extendible brush backflush instrument with active aspiration Anterior Chamber Cannula – Rycroft Eftiar Dual Bore Cannula Replacement backflush needle Sauter Hydrodissector (Curved) Olive Tip Polisher (Curved) Disposable VFI cannula Backflush instrument with active aspiration Viscoelastic Cannula Angled Extendible subretinal injection needle Backflush Instrument with brush needle and active aspiration. Sub – Tenon’s Cannula, curved with flattened tip Disposable Dual bore BSS injection needle Backflush Instrument with blunt needle and active aspiration Spaide soft-tipped diamond dusted cannula Disposable Shiraga Triamcinolone backflush instrument Formed Irrigating Cystotome Subretinal cannula, curved Backflush Instrument with blunt needle. Backflush Needle with tapered tip Disposable subretinal injection cannula Backflush Instrument with brush needle. Disposable Backflush instrument, with brush needle and passive aspiration Extendible subretinal injection cannula Disposable Microscissors: Straight Microscissors: Vertical Microscissors: Ovali Spatula / Scissors Microscissors: Straight Disposable Microscissors: Vertical Disposable Microscissors: Curved, Horizontal Microscissors: Curved, Horizontal EVA TDC Vitrectomy Pack VGPC Input 27G, Ultra short Cleaning adaptor for phaco sleeve Disposable EVA Drapes Disposable EVA VGPC Input Set VFI Pack for Silicone Oil syringes EVA Flight Case Disposable High Speed TDC Cutter DORC Continuum range Disposable phaco set with 45 straight flared needle Exo diathermy handle with 45 curved tip, diameter 1.3 mm. Disposable phaco fragmentation needle, incl. wrench 27G Ultra Short Disposable 8000 CPM TDC cutter Disposable phaco set with 45 angled flared needle Test chamber for phaco handpiece Triple step angled flared phaco needle 27G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depressor Safety filter for Zeiss/Moeller-Wedel Microscopes, Passive Universal PVC infusion line for 23G cannula system for VFI/VFE Featherlight micro Phaco emulsification/fragmentation handpiece. Safety filter for Zeis/Moeller-Wedel Microscopes, Manual Disposable infusion sleeve Disposable EVA Gravity Input Set Straight phaco needle Reusable phaco set with 30 straight flared needle EVA Cartridge with 0.5 L Collection Bag EVA Vitrectomy Pack Gravity Input Triple step flared phaco needle Reusable phaco set with 30 angled flared needle Safety filter for Leica Microscopes, Passive Triple step angled flared phaco needle. (disposable) Triple step flared phaco needle. (disposable) Endo-diathermy handle, straight pointed tip.(20 gauge / 0.9 mm) EVA Dust Cover Straight phaco needle. (disposable) Disposable test chamber for phaco handpiece Reusable phaco set with 45 angled flared needle Disposable EVA Accessory Set EVA Vitrectomy Pack VGPC Input Two Dimensional Cutter – 16k CPM EVA Custom TDC Vitrectomy Pack VGPC Input Disposable High Speed Cutter Disposable phaco set with 30 straight flared needle Endo-diathermy handle, straight pointed tip. Reusable phaco sleeve Disposable EVA Irrigation and Aspiration Tubing Reusable phaco set with 45 straight flared needle Disposable EVA Air Fluid Dual Tubing EVA TDC Vitrectomy Pack Gravity Input Disposable EVA Collection Bag 0.5 L EVA TDC Vitrectomy Pack VGPC Input Phaco Sure Touch Handpiece Safety filter for Leica Microscopes, Manual Universal I/A handpiece, excl. tips Cleaning adapter for phaco needle Disposable EVA Double Irrigation Line with Air Exchange Bimanual irrigation/aspiration set Disposable infusion sleeve phaco needle including test chamber Bipolar Coagulation Forceps, 12 cm, angled, excl. cable Disposable frosted scleral depressor EVA Mayo Arm Diathermy cable Disposable tubings complete with filter for air-fluid exchange Irrigation sleeve for phaco needle. Straight tip for universal I/A handpiece Phaco emulsification handpiece. Disposable phaco set with 30 angled flared needle Curved tip for universal I/A handpiece Universal metal wrench for star phaco needles Disposable EVA Closure Plug Aspiration Scleral Buckling Products Cryo Probe: Extended Retinal, 2.5mm Disposable High-Speed Vitrectome Disposable Drapes Phaco needle with sleeve. Disposable Fluid Giving set Disposable I/A replacement Tubing set Infusion sleeve for phaco needles Disposable Phaco Pack Disposable phaco needle wrench Phaco fragmentation needles Global pressure tubing including duck valve and Fluid Giving set. Vented Global Pressure Control Set to be used with Associate Cartridge Disposable Pneumatic Vitrectome Disposable Associate Cartridge Illuminated Laser Probe, Curved Illuminated Stepped Laser Probe, Curved With tapered tip Ophthalmologic speculum, reusable MVR Blade angled Slit Knife angled 45, bibevel Crescent Knife, bevel up Clear Corneal Knife, angled Trapezoid Knife angled Stab Knife, 15 MVR Blade straight Slit Knife, angled, bevel up Cryostar Microforceps: End-gripping Disposable Microforceps: Extended reach – Wide grip Microforceps: Serrated Jaws Microforceps: Diamond-dusted Disposable Microforceps: Eckardt End-gripping Microforceps: Horizontal Subretinal Microforceps: Asymmetrical endgripping Disposable Microforceps: ILM DMEK Graft Manipulation Forceps with extra fine tips for intraocular and extraocular unrolling of the graft. Microforceps: Eckardt End-gripping Accessory: Protection cap for microforceps & microscissors. Infusion cannula forceps Disposable Microforceps: End-gripping Disposable Microforceps: Ultra peel Disposable Microforceps: Shah Micro Serrated Jaws Microforceps: Avci Foreign Body Scleral plug forceps Scharioth IOL Scleral fixation forceps, straight & curved Microforceps: ILM Micro Capsulorhexis forceps intraocular style Microforceps: Shah Micro Serrated Jaws Forceps for removal of cannulas Microforceps: High Myopic Eckardt End-gripping Akgul Biopsy Forceps with sharp tip Microforceps: Eckardt Power End-gripping Disposable Microforceps: Asymmetrical endgripping

Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device