IC-8 Apthera IOL +25.0 DRecalls & reported problems
Bausch & Lomb Incorporated · One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens. · Class 3 · Implant
All models of IC-8 Apthera IOL (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813359021035), received between Mar 5, 2025 and Nov 13, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Visual Disturbances2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 2 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT WAS HAPPY WITH THEIR VISUAL ACUITY BUT EXPERIENCED GHOST IMAGES. APPROXIMATELY 3 MONTHS AFTER THE ONSET OF THE PROBLEM, THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL IOL DUE TO UNRESOLVED GHOST IMAGES. PATIENT OUTCOME IS GOOD, GHOST IMAGES HAVE RESOLVED.
Patient problems: Visual Disturbances
MAUDE report 23542421 ↗InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT NINE MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE IOL WAS EXCHANGED WITH A DIFFERENT MODEL LENS DUE TO THE PATIENT EXPERIENCING A SHADOW ON THE PERIPHERAL SIDE OF THE LEFT EYE FOR 7 MONTHS THAT HADN'T RESOLVED. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS NEGATIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Visual Disturbances
MAUDE report 21529937 ↗
Other Extended Depth Of Focus Intraocular Lens devices
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens101 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens1 recall49 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens93 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens87 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 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.
How reports and recalls are matched · Editorial policy · Report an error on this page