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Terminated

RT-5100 Refractor, a component of the Epic-5100 System.

FDA Recall Z-0655-2019 · Posted None

Recalling FirmNidek Inc.
Recall StatusTerminated
Product CodeHKN
Date Initiated2018-06-14
Date Terminated2020-06-03
Product Quantity85 instruments

Reason for Recall

The lens bonding was incomplete on the refractor.

Firm Action

The recalling firm called the sole distributor on 6/14/2018 to determine the quantity of instruments still in their control. During the phone call, the distributor was also notified of the invoice numbers that show the serial numbers involved, was asked to segregate the affected product, and a schedule was discussed for the recalling firm's technicians to visit the distributor for correction of the product.

Root Cause

Employee error

Distribution Pattern

Distribution was made to FL.

Official Source

View FDA Recall →

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

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