DEVICE CLASS
Class III
REGULATION
21 CFR 886.3600
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
10
510(K)/PMA CLEARANCES
pma: 10
0
RECALL ENTRIES
Recent clearances
P930014Alcon Laboratories, Inc. · pma2026-07-08
P190018Alcon Laboratories, LLC · pma2026-07-06
P100016Carl Zeiss Meditec Production, LLC · pma2026-06-10
P990080Johnson & Johnson Surgical Vision, Inc. · pma2026-06-03
P980040Johnson & Johnson Surgical Vision, Inc. · pma2026-06-03
P090022Lenstec, Inc. · pma2026-04-15
P060011Rayner Intraocular Lenses , Ltd. · pma2026-01-20
P060022Bausch & Lomb, Inc. · pma2025-09-30
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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