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OCULUS OPTIKGERATE GMBH FDA Inspection Record

FEI 3002807782 · Inspections, Form 483s, warning letters and import refusals

OCULUS OPTIKGERATE GMBH is an FDA-registered facility (FEI 3002807782) located in WETZLAR Hesse, DE. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Nov 10, 2016: No Action Indicated (NAI)
Inspections on record
3 (2 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
3, latest Aug 8, 2023
Import refusals
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Nov 10, 2016No Action Indicated (NAI)No citations listed
Sep 19, 2013Voluntary Action Indicated (VAI)No citations listed
Jun 24, 2010Voluntary Action Indicated (VAI)Document review, approval by designated individual (21 CFR 820.40(a))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Aug 8, 2023Class IIZ-2482-2023Oculus Pentacam AXL Wave, Ref 70020, CE 0123 and 2 more products
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Jul 8, 2022Class IIZ-1672-2022Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. and 2 more products
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning…
Nov 21, 2017Class IIZ-0635-2018OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and…
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value

FDA record score

6 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

5 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-2482-2023, this FEI as the recalling firmAug 8, 20234 x 0.62.4
Class II recall Z-1672-2022, this FEI as the recalling firmJul 8, 20224 x 0.62.4
Class II recall Z-0635-2018, this FEI as the recalling firmNov 21, 20174 x 0.251
Inspection classified VAISep 19, 201310 years or older, so it adds no points0
Inspection classified VAIJun 24, 201010 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Oculus Optikgeraete GMBH
Location
WETZLAR Hesse (DE)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.