Callisto Eye
Catalogue number 3.5.1, listed by Carl Zeiss Meditec Inc, United States, under Microscope, Surgical. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Guangxi (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Carl Zeiss Meditec Inc, United States |
|---|---|
| FDA product code | EPT |
| Device type | Microscope, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K141068 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.5.1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jedmed | Jedmed Instrument Company | 144 |
| Seiler Medical Division | Seiler Instrument AND Manufacturing Company, Incorporated | 87 |
| Microscope | Ecleris SRL | 58 |
| M320 Optics Carrier | Leica Microsystems (Schweiz) AG | 11 |
| Microscope, Surgical | Karl Storz GmbH & Co. KG | 10 |
| BR Surgical, LLC | BR Surgical LLC | 8 |
| Vitom | Karl Storz GmbH & Co. KG | 8 |
| Quintus | Karl Storz GmbH & Co. KG | 7 |
| Extaro 300 | Carl Zeiss Meditec (Suzhou) Co., Ltd. | 6 |
| G-Series 3-STEP Microscope With 120 Degree Angled Coupler, AND Dental Composite | Global Surgical Corp. | 5 |
| G-Series 4-STEP Microscope With 120 Degree Angled Counterbalance Coupler, White | Global Surgical Corp. | 4 |
| Microcast | Karl Storz GmbH & Co. KG | 4 |
Showing 12 of 290. All products under Microscope, Surgical
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-04-18 | Class II | Under Investigation by firm | Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower sec | 6 units | 2013-06-26 |
| 2011-09-26 | Not classified | Nonconforming Material/Component | An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations. | 3 | 2011-11-04 |
| 2011-09-12 | Not classified | Pending | Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems. | 1677 consignees | 2012-02-24 |
| 2009-05-18 | Not classified | Labeling mix-ups | Potential Retina Damage– An error in the user manual may result in misapplied filter and injury during treatment. | 2540 units | 2011-02-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.