← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

MFKLens, Multifocal Intraocular

DEVICE CLASS
Class III
REGULATION
21 CFR 886.3600
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
ImplantLife-sustainingGMP-exemptThird-party review eligible
4
510(K)/PMA CLEARANCES
pma: 4
0
RECALL ENTRIES

Recent clearances

P040020Alcon Research, Ltd. · pma2026-07-06
P080010Johnson & Johnson Surgical Vision, Inc. · pma2026-06-03
P200020Lenstec, Inc. · pma2026-04-15
P240005Bausch & Lomb, Inc. · pma2025-07-30

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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