Home › Chongqing Yeasn Science & Technology Co.,Ltd. › YEASN

YEASN

Chongqing Yeasn Science & Technology Co.,Ltd. · Model YF-100 · UDI-DI 06971922135030

HJO

510(k) clearances

217

Adverse events

Recalls

Facilities

Description

For eye examination and aid in the diagnosis. Contraindications: none. Target groups of patients: adults, children. Intended users: optometrists in hospital ophthalmology and optical shops. The people who use this product are ophthalmologists in hospitals or clinics, and optometrists in optical shops. To operate this product, they should have relevant knowledge of eye examinations and have the relevant skills to operate the product.

Recalls

Date	Firm	Reason
2021-04-15	Haag-Streit USA Inc	Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
2020-12-07	Carl Zeiss Meditec AG	When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the p
2018-06-25	Carl Zeiss Meditec AG	Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures
2016-07-01	Nidek Inc	Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
2015-10-27	Carl Zeiss Meditec AG	IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
2015-10-27	Carl Zeiss Meditec AG	IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
2013-10-23	Carl Zeiss Meditec, Inc.	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
2013-10-23	Carl Zeiss Meditec, Inc.	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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.