AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28— 510(k) K063694

Substantially Equivalent

Bausch & Lomb, Inc.

FDA 510(k) clearance K063694 for AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28, Substantially Equivalent on 2007-03-07. Applicant: Bausch & Lomb, Inc..

Clearance details

Applicant: Bausch & Lomb, Inc.
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 2006-12-13
Decision date: 2007-03-07
Decision: Substantially Equivalent
Clearance type: Special
Location: San Dimas, CA, US

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Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

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.