DEVICE CLASS
Class III
REGULATION
21 CFR 886.5925
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
pma: 9
0
RECALL ENTRIES
Recent clearances
P080011CooperVision, Inc. · pma2026-07-07
P010019Alcon Laboratories, Inc. · pma2026-05-29
P040045Vistakon, Division of Johnson & Johnson Vision Car · pma2026-05-04
N18033Vistakon, Johnson & Johnson Vision Products, Inc. · pma2026-04-17
P220007Alcon Laboratories, Inc. · pma2026-03-11
P890023The Cooper Companies · pma2025-12-11
P170035Bausch and Lomb, Inc., · pma2025-12-04
N16895Bausch & Lomb, Inc. · pma2025-10-24
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.