IOSERT LENS IMPLANT INSTRUMENT— 510(k) K854197

Name: FDA 510(k) clearance K854197
Creator: U.S. Food and Drug Administration
Published: 1986-01-22

Substantially Equivalent

Chiron Vision Corp.

FDA 510(k) clearance K854197 for IOSERT LENS IMPLANT INSTRUMENT, Substantially Equivalent on 1986-01-22. Applicant: Chiron Vision Corp.. Device class: 1.

Clearance details

Applicant: Chiron Vision Corp.
Product code: Code KYB
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 1985-10-15
Decision date: 1986-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

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.