IC-8 Apthera IOL +24.0 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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813359021011), received between Dec 13, 2023 and Aug 19, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information2
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION WAS RECEIVED WITH THE SURGEON INDICATING NO ISSUES WITH THE IOL. LENS EXCHANGE WAS PERFORMED TWO WEEKS AFTER THE ORIGINAL IMPLANT DUE TO VISION ISSUES SUCH AS NOT SEEING WELL, VERY DIM AND LOOKING THROUGH A KEYHOLE.
Patient problems: Insufficient Information
MAUDE report 22841449 ↗InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY 11 WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE IOL WAS EXCHANGED FOR A LENS OF A DIFFERENT MODEL AND DIOPTER. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 19557240 ↗InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY ONE WEEK AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE PATIENT REPORTED GLARE AND STARBURSTS. APPROXIMATELY 3 WEEKS AFTER IMPLANTATION, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Visual Disturbances
MAUDE report 18322652 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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