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Terminated

AUTO REF/KERATOMETER ARK-1s

FDA Recall Z-1348-2018 · Posted None

Recalling FirmNidek Inc.
Recall StatusTerminated
Product CodeHKO
Date Initiated2017-12-20
Date Terminated2019-03-18
Product Quantity63 untis

Reason for Recall

There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.

Firm Action

Customers were notified via letter on about 12/20/2017. The letter instructed consignees that a representative from Marco Ophthalmic, Inc. will make arrangements for the affected unit to be picked up and replaced with an ARK-S unit that meets factory specifications.

Root Cause

Equipment maintenance

Distribution Pattern

Distributed domestically to AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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