DEVICE CLASS
Class III
REGULATION
21 CFR 886.3600
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
✓ Implant— Life-sustaining— GMP-exempt— Third-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
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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