Bausch + Lomb PreVue Inserter for enVista Preloaded— 510(k) K192005

Substantially Equivalent

Bausch & Lomb, Inc.

FDA 510(k) clearance K192005 for Bausch + Lomb PreVue Inserter for enVista Preloaded, Substantially Equivalent on 2019-10-04. Applicant: Bausch & Lomb, Inc..

Clearance details

Applicant: Bausch & Lomb, Inc.
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2019-07-29
Decision date: 2019-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSS

product code MSS

Injury: 385
Malfunction: 2,033
Total: 2,418

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.