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AcrySof® ReSTOR® Aspheric UV Absorbing TORIC IOL

Alcon Laboratories, Inc. · Model SA25T4 · UDI-DI 00380652348331

MFK Prescription
0
510(k) clearances
12,970
Adverse events
4
Recalls
18
Facilities

Description

Sterile UV Absorbing Hydrophobic Acrylic Foldable Single-piece Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens

Recalls

DateFirmReason
2025-03-27Bausch & Lomb Surgical, Inc.In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVist
2006-12-14Alcon Laboratories, IncIntraocular lenses exposed to extreme temperatures while in storage.
2006-12-14Alcon Laboratories, IncIntraocular lenses exposed to extreme temperatures while in storage.
2006-12-14Alcon Laboratories, IncIntraocular lenses exposed to extreme temperatures while in storage.

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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.