REZOOM IOL NXG1 (REF NXG1BU0165)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · NXT GEN ACRY 13.0MM 6OPT MOD C PMMA OPTG · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474520196), received between May 30, 2020 and May 30, 2020 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IN 2006, PATIENT WAS IMPLANTED WITH AN INTRAOCULAR LENS IN BOTH EYES. REPORTEDLY PATIENT WAS EXPERIENCING BLURRY VISION AND HAD A HOST OF ISSUES WITH HER EYES INCLUDING BUT NOT LIMITED TO MACULAR BUCKLING. PER ACCOUNT, PATIENT WAS INQUIRING IF THE LENS WAS PART OF ANY RECALL. THEY WERE INFORMED THAT THERE WAS NO RECALL RELATED TO THIS LENS. THE ACCOUNT WAS NOT ABLE TO MONITOR PATIENT REGULARLY DUE TO A FACILITY FIRE. ACCOUNT SAW THE PATIENT IN 2014 AND THEN AGAIN IN 2019. PATIENT HAS SEEN MANY HEALTHCARE PROVIDERS AND STATED THAT BLURRY VISION HAS PERSISTED FOR A LONG TIME. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR PATIENT¿S LEFT EYE. NO FURTHER INFORMATION PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 10103728 ↗
Other LENS, MULTIFOCAL INTRAOCULAR devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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