BAUSCH + LUMB, VIS100 INJECTOR SYSTEM— 510(k) K133146

Substantially Equivalent

Bausch & Lomb

FDA 510(k) clearance K133146 for BAUSCH + LUMB, VIS100 INJECTOR SYSTEM, Substantially Equivalent on 2014-01-03. Applicant: Bausch & Lomb.

Clearance details

Applicant: Bausch & Lomb
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2013-10-17
Decision date: 2014-01-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, 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.