PASSPORT FOLDABLE LENS PLACEMENT SYSTEM— 510(k) K951292

Substantially Equivalent

Chiron Vision Corp.

FDA 510(k) clearance K951292 for PASSPORT FOLDABLE LENS PLACEMENT SYSTEM, Substantially Equivalent on 1995-06-02. Applicant: Chiron Vision Corp..

Clearance details

Applicant: Chiron Vision Corp.
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 1995-03-22
Decision date: 1995-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Lorenzo, PR, US

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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.