UNFOLDER EMERALD AR 1CART30Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · MODEL 1CART30 CARTRIDGE · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474534469), received between Jul 25, 2019 and Jul 25, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Deformation3
Patient problems
- No Patient Involvement3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THERE WERE 3 CARTRIDGES THAT APPEARED TO HAVE A SHARP/WARPED, AND MELTED TIPS, UPON ATTEMPTED IMPLANTATION, THE LEADING HAPTIC BROKE/SHEARED OFF BY THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT IS FOR #2 OF THE 3 REPORTED EVENTS. A SEPARATE REPORT IS BEING FILED FOR EACH OF THE 3 CARTRIDGES.
Patient problems: No Patient Involvement
MAUDE report 8825039 ↗MalfunctionJul 25, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THERE WERE 3 CARTRIDGES THAT APPEARED TO HAVE A SHARP/WARPED, AND MELTED TIPS, UPON ATTEMPTED IMPLANTATION, THE LEADING HAPTIC BROKE/SHEARED OFF BY THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT IS FOR #1 OF THE 3 REPORTED EVENTS. A SEPARATE REPORT IS BEING FILED FOR EACH OF THE 3 CARTRIDGES.
Patient problems: No Patient Involvement
MAUDE report 8825035 ↗MalfunctionJul 25, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THERE WERE 3 CARTRIDGES THAT APPEARED TO HAVE A SHARP/WARPED, AND MELTED TIPS, UPON ATTEMPTED IMPLANTATION, THE LEADING HAPTIC BROKE/SHEARED OFF BY THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT IS FOR #3 OF THE 3 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 3 CARTRIDGES.
Patient problems: No Patient Involvement
MAUDE report 8825027 ↗
Other LENS, GUIDE, INTRAOCULAR devices
- MONARCH® III 8065977763Alcon Laboratories, Inc. · LENS, GUIDE, INTRAOCULAR1 recall1,042 reports
- UNFOLDER PLATINUM 1 SERIES 1MTEC30Johnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR524 reports
- MONARCH® III 8065977773Alcon Laboratories, Inc. · LENS, GUIDE, INTRAOCULAR338 reports
- UNFOLDER EMERALD EMERALDCJohnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR250 reports
- UNFOLDER SILVER PSCSTJohnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR66 reports
- MONARCH® II 8065977758Alcon Laboratories, Inc. · LENS, GUIDE, INTRAOCULAR22 reports
- ONE SERIES ULTRA 1VIPR30Johnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR8 reports
- UNFOLDER EMERALD EMERALDTJohnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.