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IQ RESTOR ®
Monoflex®
ACRYSOF® IQ RESTOR ® Monoflex®
Alcon Laboratories, Inc. · Model MN6AD1 · UDI-DI 00380652262811
MFK
Prescription
0
510(k) clearances
12,970
Adverse events
4
Recalls
18
Facilities
Description
AcrySof(R) IQ ReSTOR(R) APODIZED DIFFRACTIVEMULTIPIECE STERILE PCL(IOL/PC) 13.0mm LENGTH 6.0mm OPTIC 10-DEGREE Monoflex(TM*) HAPTICS.*REG. U.S. PAT. & TM OFF.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-27 | Bausch & 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 |
| 2006-12-14 | Alcon Laboratories, Inc | Intraocular lenses exposed to extreme temperatures while in storage. |
| 2006-12-14 | Alcon Laboratories, Inc | Intraocular lenses exposed to extreme temperatures while in storage. |
| 2006-12-14 | Alcon Laboratories, Inc | Intraocular lenses exposed to extreme temperatures while in storage. |
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Get your free API keyRead the docsData 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.