IC-8 Apthera IOL +27.0 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 00813359021073), received between Feb 9, 2024 and Feb 20, 2024 — 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
- Halo2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Corneal Edema1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT''S SYMPTOMS BEGAN APPROXIMATELY SIX WEEKS AFTER IMPLANTATION OF THE INITIAL IOL. THE PATIENT STATED THEY FELT SOMETHING WAS BLOCKING THEIR VISION. SLIGHT NASAL DECENTRATION WAS NOTED AT SLIP LAMP DURING SURGERY FOR EXCHANGE.
Patient problems: Halo; Visual Disturbances
MAUDE report 18744553 ↗InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT COMPLAINED OF DIMNESS AND HALOS. APPROXIMATELY THREE MONTHS AFTER IMPLANTATION, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL. IN THE SURGEON''S OPINION, THE MOST LIKELY CAUSE IS PATIENT ADAPTATION. PATIENT HAS NOT YET RECOVERED, HAS PERSISTENT CORNEAL EDEMA.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Halo
MAUDE report 18677985 ↗
Other Extended Depth Of Focus Intraocular Lens devices
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- 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.
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