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OPTICAL BIOMETER

NIDEK CO.,LTD. · Model AL-Scan · UDI-DI 04987669100547

HJO IYO Prescription

510(k) clearances

217

Adverse events

Recalls

Facilities

Description

The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method. An optional A-scan probe is also available to scan axial length with an ultrasonic measurement function by touching it to the cornea should optical measurement not be successful. In addition, an anterior eye segment image overlaid with the corneal meridians can be created as a reference for toric IOL implantation. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.

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

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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.