IOLMaster 500
The IOLMaster 500 measures the eye without contact to support planning for intraocular lens implantation. It provides measurements including axial length, corneal radius, anterior chamber…
The IOLMaster 500 measures the eye without contact to support planning for intraocular lens implantation. It provides measurements including axial length, corneal radius, anterior chamber depth and white-to-white distance, along with pupil size and visual-axis offset.
The instrument combines partial-coherence interferometry with ophthalmic biometry techniques. Its software uses recognised calculation formulas to help physicians choose an intraocular lens type and power before cataract surgery. Measurements support the clinician’s preoperative assessment.
Listed Item
The IOLMaster is intended for the biometric determination of ocular measurements for axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.
Professional Use
The device is intended for physicians and eye-care professionals and must be used under a physician’s supervision. It measures and calculates lens-planning information rather than implanting or adjusting the lens.
Who Else Makes It
Concentrated in Jiangsu (3), Chongqing (2), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 3 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
Record
| Listed by | Carl Zeiss Meditec Inc, United States |
|---|---|
| FDA product code | HJO |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K122418 |
| Record published | 2016-03-18 |
| Record revised | 2020-11-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -10 to 55 °C; Handling environment humidity 30 to 90 % RH; Handling environment temperature 10 to 35 °C |
| Sizes | Weight 18 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IOLMaster 500 | Weight 18 kg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MediWorks | Shanghai Mediworks Precision Instruments Co., Ltd. | 30 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 24 |
| Marco | Takagi Seiko Co., Ltd. | 17 |
| Gilras | U.S. Ophthalmic, L.L.C. | 16 |
| Visionix | Luneau Technology Operations | 15 |
| LED Slit Lamp | Right MFG. Co., Ltd. | 13 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 12 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 12 |
| Inami | Inami & Co., Ltd. | 11 |
| Zoom Slit Lamp | Right MFG. Co., Ltd. | 8 |
| Slit Lamp BQ 900 | Haag-Streit AG | 8 |
| PolyLock Small Bone | Fusion Orthopedics, LLC | 7 |
Showing 12 of 168. All products under Biomicroscope, Slit-Lamp, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173771 | 2018-08-24 |
| K162684 | 2017-05-31 |
| K170171 | 2017-04-06 |
| K161607 | 2017-02-23 |
| K143275 | 2015-07-10 |
| K141068 | 2014-09-09 |
| K133476 | 2014-02-12 |
| K122418 | 2013-04-12 |
| K101182 | 2010-11-03 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Carl Zeiss Meditec AG (Jena) | 510(k) number | 2015-10-27 | Class II | Software design | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. | 49 | 2016-06-06 |
| Carl Zeiss Meditec AG (Jena) | 510(k) number | 2015-10-27 | Class II | Software design | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. | 1882 | 2016-06-06 |
| Carl Zeiss Meditec Inc | 510(k) number | 2013-10-23 | Class II | Software in the Use Environment | The user database delivered for download contained an erroneous value. Specifically the “aO” constant of the lens AMO Sensar AR40E is listed as “0.0” in the internal lens database of the IOLMaster. The correct value is -2.420. This could le | 4,907 units | 2014-04-17 |
| Carl Zeiss Meditec Inc | 510(k) number | 2013-10-23 | Class II | Software in the Use Environment | The user database delivered for download contained an erroneous value. Specifically the “aO” constant of the lens AMO Sensar AR40E is listed as “0.0” in the internal lens database of the IOLMaster. The correct value is -2.420. This could le | 1,201 units | 2014-04-17 |
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.