DeviceClearance

K073023

Substantially Equivalent

STERILS SINGLE-USE I/A HANDPIECES

Applicant
Bausch & Lomb, Inc.
Product code
HQC
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Rochester, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HQC

product code HQC
Injury
2,378
Malfunction
8,768
Total
11,146

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.