DeviceClearance

MicroSTAAR Injector System Cartridges— 510(k) K172375

Substantially Equivalent

STAAR Surgical Company

FDA 510(k) clearance K172375 for MicroSTAAR Injector System Cartridges, Substantially Equivalent on 2017-09-06. Applicant: STAAR Surgical Company.

Clearance details

Applicant
STAAR Surgical Company
Product code
Code MSS
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Monrovia, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MSS

product code MSS
Injury
385
Malfunction
2,033
Total
2,418

Source: openFDA MAUDE database, through . 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.