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U.S. Department of Health and Human Services

Class 2 Device Recall OPTICAL BIOMETER

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  Class 2 Device Recall OPTICAL BIOMETER see related information
Date Initiated by Firm July 01, 2016
Create Date August 18, 2016
Recall Status1 Terminated 3 on December 22, 2016
Recall Number Z-2587-2016
Recall Event ID 74595
510(K)Number K133132  
Product Classification Biomicroscope, slit-lamp, ac-powered - Product Code HJO
Product OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier.

Ophthalmic: 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.
Code Information OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Serial numbers: 220005, 220006, 220008, 220009, 220013, 220017, 220018, 220019, 220020, 220021, 220023, 220025, 220026, 220031, 220032, 220033, 220036. 
Recalling Firm/
Manufacturer
Nidek Inc
47651 Westinghouse Dr
Fremont CA 94539-7474
For Additional Information Contact Preeti Gandhi Bhatia
510-353-7785
Manufacturer Reason
for Recall
Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
FDA Determined
Cause 2
Software in the Use Environment
Action Dear Doctor/Recall letters were sent to affected customers on July 7, 2016. The letters describe the issue and provide instruction should the issue occur. The letters inform users that Nidek will reach out in the next few weeks to schedule installation of new software that will solve the problem. Questions or concerns may be directed to: Customer Service 1.800.722.0219; Monday- Friday 8 am to 5pm PST E-mail: AL-Scan_support@noritsuservice.com.
Quantity in Commerce 17
Distribution US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HJO and Original Applicant = NIDEK CO., LTD.
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