Carl Zeiss Meditec VISULENS 550 Recalled for Electrical Shock Risk
Carl Zeiss Meditec is recalling VISULENS 550 refractive power measurement devices due to a defective communication board that may cause electrical shocks.
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 risk-of-harm product (electrical shock) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Carl Zeiss Meditec AG is recalling 603 units of the VISULENS 550 REF 2268-038, a device used to measure the refractive power of contact lenses and spectacle lenses. The recall is due to an incorrect DC/DC converter being assembled onto the communication board.
The defective component means the safety function of the communication board is insufficient, resulting in increased leakage of current. This condition potentially causes electrical shocks to the user.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous international countries. Consumers should stop using the device and contact the manufacturer for further instructions.
The recalled product
- Product
- Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
- Manufacturer
- Carl Zeiss Meditec AG
- Hazard
- Affected units
- 603
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
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.
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