iSert Intraocular Lens 230 (clear), +22.50DRecalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04547480301365), received between Mar 3, 2017 and Mar 3, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Capsular Bag Tear1
- Vitrectomy1
- Vitreous Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2017Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE CAPSULAR BAG WAS DAMAGED DURING INSERTION OF THE LENS IN THE PATIENT'S RIGHT EYE. THE HAPTIC WAS DAMAGED AND IN THE PHYSICIAN OPINION, THE DAMAGE WAS DUE TO "HANDLING." REPORTEDLY, THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURE WAS NEEDED. THERE WAS LOSS OF VITREOUS AND A VITRECTOMY WAS PERFORMED; HOWEVER, BECAUSE OF TOO MUCH BLEEDING AND CONDITION OF THE BAG, NO LENS WAS IMPLANTED. PHYSICIAN IS EVALUATING TREATMENT OPTIONS.
Patient problems: Capsular Bag Tear; Vitrectomy; Vitreous Loss
MAUDE report 6378132 ↗
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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