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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances
  • 510(k)K162991Substantially equivalent (SESD) · 2017-07-24clearance family

Predicate lineage

K162991

Cited as predicate by: K181116, K231075

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2024-03-26NAINo action indicatedCarl Zeiss Meditec Inc.0
2018-10-25NAINo action indicatedCarl Zeiss Meditec Inc.0
2017-02-24NAINo action indicatedCarl Zeiss Meditec AG0
2016-03-25NAINo action indicatedCarl Zeiss Meditec Inc.0
2014-09-18NAINo action indicatedCarl Zeiss Meditec Inc.0
2014-08-15NAINo action indicatedCarl Zeiss Meditec AG0
2014-03-26NAINo action indicatedCarl Zeiss Meditec Inc.0
2011-11-17NAINo action indicatedCarl Zeiss Meditec Inc.0
2011-06-22NAINo action indicatedCarl Zeiss Meditec Inc.0
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