LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING— 510(k) K912253

Name: FDA 510(k) clearance K912253
Creator: U.S. Food and Drug Administration
Published: 1991-08-07

Substantially Equivalent

Ocular Instruments, Inc.

FDA 510(k) clearance K912253 for LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING, Substantially Equivalent on 1991-08-07. Applicant: Ocular Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Ocular Instruments, Inc.
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 1991-05-21
Decision date: 1991-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.