iSert Intraocular Lens 251 (yellow), +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
- 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 04547480450346), received between Aug 22, 2024 and Feb 18, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Crack1
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2026Crack
EVENT OCCURRED IN CHINA. DAMAGED OPTIC AFTER IMPLANTATION. CRACKED OR BROKEN OPTIC (MIDDLE). PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0404 - CRACK.
Patient problems: Failure of Implant
MAUDE report 24382664 ↗InjuryAug 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING; DAMAGED HAPTIC; HAPTIC DOES NOT FOLD AS PER IFU. CHINA QA UPDATED IN JUL,8 2025: BASED ON THE INITIAL REPORT SUBMITTED BY THE HOSPITAL, THE COMPLAINT WAS THAT THE HAPTIC WAS DAMAGED AFTER IMPLANTATION AND EXPLANTATION, WITH NO IMPACT ON THE PATIENT. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 22710247 ↗InjuryAug 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN TRAILING; ROOT; DAMAGED HAPTIC. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 20036274 ↗
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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