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.
This recall has been terminated (originally issued July 1, 2016).
- Company
- Nidek Inc
- Recall Initiated
- July 1, 2016
- Terminated
- December 22, 2016
- Recall Number
- Z-2587-2016
- Quantity
- 17
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.
Lot / Code Info
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.
Root Cause
Software in the Use Environment
Action Taken
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.