I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN— 510(k) K990292

Substantially Equivalent

Ophthalmic Consultants, Inc.

FDA 510(k) clearance K990292 for I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN, Substantially Equivalent on 1999-11-19. Applicant: Ophthalmic Consultants, Inc..

Clearance details

Applicant: Ophthalmic Consultants, Inc.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1999-01-29
Decision date: 1999-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tooele, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.