FDA Device Intelligence
HomeJOHNSON & JOHNSON SURGICAL VISION, INC. › REZOOM IOL

REZOOM IOL

JOHNSON & JOHNSON SURGICAL VISION, INC. · Model NXG1 · UDI-DI 05050474520004

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

Description

NXT GEN ACRY 13.0MM 6OPT MOD C PMMA OPTG

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.

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.