iSert Intraocular Lens 230 (clear), +16.00DRecalls & reported problems
Hoya Medical Singapore Pte. Ltd. · Class 3 · Implant
All models of iSert Intraocular Lens (69)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 04547480301235), received between Feb 12, 2016 and Sep 9, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break2
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2021Break; Break
BROKEN HAPTIC DURING USE; DEVICE EXPLANTATION - PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED; THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12450641 ↗MalfunctionSep 9, 2021Break; Break
BROKEN HAPTIC DURING USE; HAPTIC SHEERED OFF AT HAPTIC OPTIC JUNCTION DURING INSERTION; DEVICE EXPLANTATION - PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED; THE LENS NEVER MADE IT FULLY IN THE EYE; NO INCISION ENLARGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12450603 ↗MalfunctionFeb 12, 2016Material Protrusion/Extrusion; Material Protrusion/Extrusion
THE TRAILING HAPTIC HAD A SHARP EDGE STICKING STRAIGHT OUT THAT WOULD HAVE CUT PATIENT'S INNER EYE IF THE SURGEON HAD LEFT IOL IMPLANTED IN THE EYE. PATIENT IS IN GOOD CONDITION. NO INJURY TO THE PATIENT'S EYE AND SURGEON DID NOT HAVE TO ENLARGE THE INCISION TO REMOVE THE IOL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5434607 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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