PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR— 510(k) K893199

Name: FDA 510(k) clearance K893199
Creator: U.S. Food and Drug Administration
Published: 1989-06-16

Substantially Equivalent

Allergan Medical Optics

FDA 510(k) clearance K893199 for PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR, Substantially Equivalent on 1989-06-16. Applicant: Allergan Medical Optics. Device class: 1.

Clearance details

Applicant: Allergan Medical Optics
Product code: Code HNR
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1989-04-26
Decision date: 1989-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anasco, PR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

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.