MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM— 510(k) K073586

Substantially Equivalent

Staar Surgical Co.

FDA 510(k) clearance K073586 for MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM, Substantially Equivalent on 2008-03-13. Applicant: Staar Surgical Co..

Clearance details

Applicant: Staar Surgical Co.
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2007-12-20
Decision date: 2008-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, 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.