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IC-8 Apthera IOL

Bausch & Lomb Incorporated · Model +18.0 D · UDI-DI 00813359020892

POE Prescription
0
510(k) clearances
5,739
Adverse events
1
Recalls
16
Facilities

Description

One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.

Recalls

DateFirmReason
2023-07-06Johnson & Johnson Surgical Vision, Inc.Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.