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FDA PRODUCT CODE · CLASS III

QCB — Phakic Toric Intraocular Lens

Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.

DEVICE CLASS
Class III
REGULATION
21 CFR 886.3600
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
pma: 1
0
RECALL ENTRIES

Recent clearances

P030016STAAR Surgical Company · pma2025-12-10

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA 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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