The Recall Desk
SevereFDA (Devices)·Z-0614-2021·Announced 2020-12-23

Carl Zeiss Meditec VISUREF 150 Recalled for Electrical Shock Risk

Carl Zeiss Meditec is recalling 132 VISUREF 150 diagnostic instruments due to an incorrect component that may cause electrical shocks to users.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of electrical shock to users, which constitutes a significant injury risk. This aligns with the rubric for 'Severe' severity, which includes significant injury reports or risks.

Plain-English summary

Carl Zeiss Meditec AG is recalling 132 units of the VISUREF 150 diagnostic instrument. This device is used to determine objective refractive values and keratometric characteristics of the human eye to assist in prescribing optical aids such as eyeglasses and contact lenses.

The recall is due to an incorrect DC/DC converter being assembled onto the communication board. This defect means the effectiveness of the communication board cannot be guaranteed, as the safety function of the board is insufficient. This results in an increased leakage of current, which could potentially cause electrical shocks to the user.

The affected units were distributed worldwide, including nationwide distribution in the United States and in numerous countries across Europe, Asia, the Americas, and Africa. Consumers and healthcare providers should stop using the affected VISUREF 150 units and contact Carl Zeiss Meditec AG for further instructions.

The recalled product

Product
Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses
Manufacturer
Carl Zeiss Meditec AG
Category
Medical Device — Diagnostic Instrument
Hazard
Affected units
132

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 (1)

  • Model: VISUREF 150 Catalog Number: 000000-2227-967 Serial Numbers: Pending

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Carl Zeiss Meditec AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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