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Device, Analysis, Anterior Segment

FDA product code MXK · Class 2 · Ophthalmic

35
Registered devices
12
Adverse events
7
Recalls
23
510(k) clearances

Devices with this code

RODENSTOCK — LUNEAU TECHNOLOGY OPERATIONSHRT3 — Heidelberg Engineering GmbHMyopia Master — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungPentacam — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungVISIONIX — LUNEAU TECHNOLOGY OPERATIONSPark 1 — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungESSILOR — LUNEAU TECHNOLOGY OPERATIONSPentacam HR — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungPentacam Cornea OCT — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungOPTICAL BIOMETER — SANTEC CORPORATIONMYOPIA EXPERT 700 — VISIA IMAGING SRLPentacam AXL Wave — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungGALILEI — SIS AG, Surgical Instrument SystemsTOMOCAP — Heidelberg Engineering GmbHHRT3 — Heidelberg Engineering GmbHESSILOR — VISIA IMAGING SRLVISIONIX — LUNEAU TECHNOLOGY OPERATIONSWaveLight — Alcon Laboratories, Inc.ESSILOR — LUNEAU TECHNOLOGY OPERATIONSVISIONIX — LUNEAU TECHNOLOGY OPERATIONSGALILEI — SIS AG, Surgical Instrument SystemsMYAH — VISIA IMAGING SRLVISIONIX — LUNEAU TECHNOLOGY OPERATIONSOPTICAL BIOMETER — SANTEC CORPORATION

Recent recalls

DateFirmReason
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2017-11-21Oculus Optikgeraete GMBHThe device software versions have an anomaly which may produce an erroneous marking for the quality specification value

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.