Nidek Optical Biometer AL-Scan Recalled for Inaccurate Axial Length Measurements
Nidek Inc. is recalling 17 Optical Biometer AL-Scan devices because they measured axial lengths as much shorter than actual values.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a measurement defect that could impact surgical planning for cataract surgery. While no specific injuries or illnesses are reported in the source text, the risk of harm from inaccurate IOL power calculation justifies a High severity rating under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Nidek Inc. is recalling 17 units of the Optical Biometer AL-Scan, software version 1.09 and earlier. The device is an ophthalmic measuring instrument used to determine values necessary for calculating intraocular lens (IOL) power for cataract surgery, including axial length, corneal curvature radius, and anterior chamber depth.
The recall was initiated after Nidek Inc. received information from its manufacturer, NIDEK CO. Japan, that the axial lengths displayed by the AL-Scan were much shorter than actual measurements. This inaccuracy could affect the calculation of IOL power for cataract surgery.
The affected units were distributed in the United States in the states of New York, Pennsylvania, Georgia, Arizona, Virginia, Delaware, Maine, Missouri, Tennessee, and New Mexico. The specific serial numbers for the 17 recalled units are 220005, 220006, 220008, 220009, 220013, 220017, 220018, 220019, 220020, 220021, 220023, 220025, 220026, 220031, 220032, 220033, and 220036. Users should contact Nidek Inc. for further instructions regarding the recall.
The recalled product
- 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…
- Manufacturer
- Nidek Inc
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 220006
- 220008
- 220009
- 220013
- 220017
- 220018
- 220019
- 220020
- 220021
- 220023
- 220025
- 220026
- 220031
- 220032
- 220033
- 220036.
Distribution
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