iSert Intraocular Lens 250 (clear), +14.00DRecalls & 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547480480664), received between Oct 11, 2022 and Apr 23, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Crack1
- Material Opacification1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
EVENT OCCURRED IN (B)(6). DAMAGED HAPTIC AFTER IMPLANTATION. PROBLEM CODE: A0401 - BREAK; A0414 - MATERIAL SPLIT, CUT, OR TORN. TRAILING HAPTIC SNAPPED IN THE INJECTOR, LEADING HAPTIC AND OPTIC WENT INTO EYE, LENS NEEDED TO BE CUT INTO TWO PIECES AND REMOVED. PATIENT HEALTH NOT IMPACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19169656 ↗InjuryMar 28, 2024Crack; Crack
EVENT OCCURRED IN CHINA. FOREIGN MATTER. ON THE SECOND DAY AFTER SURGERY, THE SURGEON FOUND WHITE FLOCCULENT MATERIAL ON THE SURFACE OF THE IOL. THE FLOCCULENT WAS SURGICALLY REMOVED FROM THE ORIGINAL INCISION AND THE LENS WAS RETAINED IN THE PATIENT'S EYE. IT WAS NOTED THAT THE PATIENT HAD NO POSTOPERATIVE INFECTIONS OR OTHER PROBLEMS. NO INFECTIONS. PROBLEM CODE: A0404 - CRACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18992732 ↗InjuryOct 11, 2022Material Opacification; Material Opacification
SURGERY DATE: (B)(6) 2022. POST-OPERATIVE COMPLICATIONS: OPTIC OPACIFICATION. EXPLANTATION: PRODUCT REPLACED WITH ANOTHER LENS. PATIENT HAS RECOVERED AND IS FINE.
Patient problems: Failure of Implant
MAUDE report 15584490 ↗
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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