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CALLISTO eye

Model 3.6.2 · Carl Zeiss Meditec AG · DI 04049539104403

NFJ — System, Image Management, Ophthalmic · Class II · 21 CFR 892.2050

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

01112019-01: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device0111
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2022-1101
This device (reports/month)Average device in NFJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Carl Zeiss Meditec AG

  • NAI 2024-03-26 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2018-10-25 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2017-02-24 Carl Zeiss Meditec AG · 0 citations
  • NAI 2016-03-25 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2014-09-18 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2014-08-15 Carl Zeiss Meditec AG · 0 citations
  • NAI 2014-03-26 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2011-11-17 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2011-06-22 Carl Zeiss Meditec Inc. · 0 citations