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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92847

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 08, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Oculus Optikgeraete GMBH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Oculus Pentacam AXL Wave, Ref 70020, CE 0123

Z-2482-2023
Recall number
Z-2482-2023
Initiated
August 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Oculus Optikgeraete GMBH
Quantity
143 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

Code information

UDI-DI; (01) 04049584025357

Distribution pattern

US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided

device · product 2 of 3

Oculus Pentacam AXL , Ref 70100, CE 0123

Z-2483-2023
Recall number
Z-2483-2023
Initiated
August 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Oculus Optikgeraete GMBH
Quantity
364 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

Code information

UDI-DI; (01) 04049584012333

Distribution pattern

US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided

device · product 3 of 3

Oculus Myopia Master , Ref 68100, CE 0123

Z-2484-2023
Recall number
Z-2484-2023
Initiated
August 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Oculus Optikgeraete GMBH
Quantity
173 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

Code information

UDI-DI; (01) 04049584026095

Distribution pattern

US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided