iSert Intraocular Lens 250 (clear), +23.50DRecalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04547480480855), received between Aug 2, 2018 and Oct 16, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Material Split, Cut or Torn2
- Adverse Event Without Identified Device or Use Problem1
- Scratched Material1
Patient problems
- Failure of Implant3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Visual Disturbances1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; DAMAGED HAPTIC. "THE HOSPITAL REPORTED THE INCIDENT AS A SERIOUS ADVERSE EVENT TO CHINA AUTHORITY. DUE TO THE PATIENT'S ADVANCED AGE, ANOTHER IOL COULD NOT BE REPLACED, AND THE ORIGINAL ONE REMAINED IN THE EYE AFTER CLINICAL ASSESSMENT. THE PATIENT RETURNED THE NEXT DAY FOR FOLLOW-UP, AND THE IOL WAS CONFIRMED TO BE PROPERLY POSITIONED." THE SURGICAL IMAGE CAN BE FOUND IN THE ATTACHMENT. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23319199 ↗InjuryJun 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2024. PROBLEM CODE: (B)(6), MATERIAL SPLIT CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 19493968 ↗InjuryNov 16, 2023Scratched Material; Scratched Material
EVENT OCCURRED IN CHINA. DAMAGED OPTIC AFTER IMPLANTATION. IMDRF CODE: A0415, SCRATCH MATERIAL. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. IOL WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 18156770 ↗InjuryMay 24, 2022Break; Break
DAMAGED HAPTIC AFTER IMPLANTATION. TORN TRAILING HAPTIC. DEVICE EXPLANTED. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED
Patient problems: Failure of Implant
MAUDE report 14482013 ↗InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IMPLANT DATE: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. EVENT OCCURRED IN (B)(6). MANUFACTURER'S DATE OF AWARENESS: 19 APR 2022. INFLAMMATION; CORNEAL EDEMA, BULBAR HYPEREMIA, BLURRY VISION, EYE PAIN, CELL ADHESION. PATIENT CONDITION AND SYMPTOMS: VISUAL DISTRIBANCES. HEALTH IMPACT: MEDICATION REQUIRED.
Patient problems: Visual Disturbances
MAUDE report 14418559 ↗InjuryFeb 22, 2021Break; Break
BROKEN HAPTIC DURING USE; POSTERIOR HAPTIC BROKE OFF DURING IMPLANTATION. WOUND STRETCH; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11362547 ↗InjuryAug 2, 2018Break; Break
IT WAS REPORTED THAT THE BROKEN BACK HAPTIC WAS NOTICED UPON INSERTION. THE LENS WAS REMOVED AND REPLACED. THE INCISION WAS ENLARGED (3.2MM) AND 1 SUTURE WAS PLACED. PATIENT OUTCOME AND TREATMENT IS GOOD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7745312 ↗
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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