iSert Intraocular Lens 250 (clear), +20.50DRecalls & 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
- 9
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04547480480794), received between May 10, 2019 and Jul 3, 2025 — classified as 7 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Material Split, Cut or Torn3
- Device Appears to Trigger Rejection1
- Scratched Material1
Patient problems
- Failure of Implant4
- No Known Impact Or Consequence To Patient4
- Toxic Anterior Segment Syndrome (TASS)1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. THE COMPLAINT IS ABOUT THE DAMAGED HAPTIC AFTER IMPLANTATION AND THE INITIAL SURGERY REQUIRED EXPLANTATION. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 22401259 ↗InjuryMay 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. MIDDLE; DAMAGED HAPTIC. INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 22102055 ↗InjuryNov 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING; ROOT; DAMAGED HAPTIC. INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 20789169 ↗InjuryMay 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
EVENT OCCURRED IN INDIA. ORIGINALLY ASSESSED AS NOT REPORTABLE PER MVPI INDIA GUIDELINE, 11-03-2020. OVD USED WAS REPORTED AS "UNKNOWN." TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS REPORTED. IMPLANT DATE: (B)(6) 2021; ONSET > 5 DAYS AFTER IMPLANTATION. PATIENT IMPACT: PATIENT HAS RECOVERED AND IS FINE.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 17015035 ↗InjuryFeb 21, 2023Scratched Material; Scratched Material
EVENT OCCURRED IN (B)(6). A DAMAGED HAPTIC AFTER IMPLANTATION FOLLOWED BY AN EXPLANTATION WERE REPORTED. THE PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. NO PERMANENT OR NEGATIVE IMPACT ON PATIENT'S HEALTH IS EXPECTED.
Patient problems: Failure of Implant
MAUDE report 16410619 ↗InjuryJun 11, 2019Break; Break
TORN HAPTIC - IOL HAD TO BE EXPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8689704 ↗InjuryJun 11, 2019Break; Break
TRAILING HAPTIC BROKE. LENS WAS EXPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8689665 ↗MalfunctionMay 10, 2019Break; Break
BROKE HAPTIC DURING IOL INSERTION. THE LENS WAS NOT IMPLANTED BECAUSE IT DID NOT EJECT. LENS WAS STUCK IN CARTRIDGE TIP. PATIENT IMPACT: NO IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8600854 ↗MalfunctionMay 10, 2019Break; Break
BROKE HAPTIC DURING IOL INSERTION. THE LENS IS STILL IN THE PATIENT'S EYE - LENS NOT EXPLANTED. PATIENT IMPACT: NO IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8600713 ↗
Other Intraocular Lens devices
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- 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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