UNFOLDER Vitan Inserter— 510(k) K191949

Substantially Equivalent

Johnson & Johnson Surgical Vision, Inc.

FDA 510(k) clearance K191949 for UNFOLDER Vitan Inserter, Substantially Equivalent on 2019-09-13. Applicant: Johnson & Johnson Surgical Vision, Inc..

Clearance details

Applicant: Johnson & Johnson Surgical Vision, Inc.
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2019-07-22
Decision date: 2019-09-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Santa Ana, 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.