DeviceClearance

K082944

Substantially Equivalent

CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

Applicant
Bausch & Lomb, Inc.
Product code
MSS
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rochester, NY, 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, 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.