MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER— 510(k) K011392

Substantially Equivalent

Micra Instruments

FDA 510(k) clearance K011392 for MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER, Substantially Equivalent on 2001-10-22. Applicant: Micra Instruments.

Clearance details

Applicant: Micra Instruments
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2001-05-07
Decision date: 2001-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luton, Bedfordshire, GB

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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.