IC-8 Apthera IOL +29.5 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 00813359021127), received between May 9, 2024 and Oct 17, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
IT WAS REPORTED THAT EIGHT DAYS POST IMPLANT OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT COMPLAINED OF NOTICING A DECREASE IN VISION. DURING EXAMINATION, THE SURGEON FOUND THE HAPTIC WAS BROKEN AND THE LENS HAD DISLOCATED. A SUCCESSFUL LENS EXCHANGE USING THE SAME MODEL AND DIOPTER WAS COMPLETED APPROXIMATELY FOUR WEEKS AFTER INITIAL IMPLANT. THE PATIENT'S OUTCOME IS GOOD.
Patient problems: Visual Impairment
MAUDE report 20470810 ↗InjuryMay 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE IOL CAME OUT OF THE INJECTOR WITH A TEAR IN THE OPTIC., ALLEGEDLY DAMAGED DURING LOADING OR INSERTION. THE IOL WAS REPLACED INTRAOPERATIVELY, AND A SUTURE WAS USED TO CLOSE THE WOUND. THE PATIENT HAS RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19278179 ↗
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- 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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