LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES— 510(k) K050638

Substantially Equivalent

Lenstec, Inc.

FDA 510(k) clearance K050638 for LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES, Substantially Equivalent on 2005-05-31. Applicant: Lenstec, Inc..

Clearance details

Applicant: Lenstec, Inc.
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2005-03-11
Decision date: 2005-05-31
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.