Oculus Optikgeraete GMBH

Complete recall history across all FDA and CPSC categories — 7 total recalls

Oculus Optikgeraete GMBH appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (7)

FDA medical device enforcement actions by Oculus Optikgeraete GMBH

Date Product Reason Class
Aug 8, 2023 Oculus Pentacam AXL Wave, Ref 70020, CE 0123 Their is a potential that optical devices with insufficient anti-reflective ... Class II
Aug 8, 2023 Oculus Myopia Master , Ref 68100, CE 0123 Their is a potential that optical devices with insufficient anti-reflective ... Class II
Aug 8, 2023 Oculus Pentacam AXL , Ref 70100, CE 0123 Their is a potential that optical devices with insufficient anti-reflective ... Class II
Jul 8, 2022 Pentacam HR REF 70900. Used to image the anterior segment of the eye. Due to a software issue, IOL calculator printout often does not accurately re... Class II
Jul 8, 2022 Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. Due to a software issue, IOL calculator printout often does not accurately re... Class II
Jul 8, 2022 Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior... Due to a software issue, IOL calculator printout often does not accurately re... Class II
Nov 21, 2017 OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11... The device software versions have an anomaly which may produce an erroneous m... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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