LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM— 510(k) K060533

Substantially Equivalent

Lenstec, Inc.

FDA 510(k) clearance K060533 for LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM, Substantially Equivalent on 2006-04-14. Applicant: Lenstec, Inc..

Clearance details

Applicant: Lenstec, Inc.
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2006-02-28
Decision date: 2006-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

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Adverse events under product code MSS

product code MSS

Injury: 385
Malfunction: 2,033
Total: 2,418

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.