iSert Intraocular Lens 230 (clear), +21.00DRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547480301334), received between Jan 11, 2021 and Jun 16, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Most reported problems
Device problems
- Material Twisted/Bent2
- Fracture1
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.
MalfunctionJun 16, 2022Fracture; Fracture
CRACKED OR DEFORMED CARTRIDGE/TIP. IOL GOT STUCK IN THE NOZZLE DURING INSERTION; LENS INJECTOR TIP CRACKED DURING INSERTION. LENS WAS STILL ABLE TO BE IMPLANTED. NO INCISION ENLARGEMENT, BUT SUTURES WERE REQUIRED. PATIENT CONDITION: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. HEALTH IMPACT: MODIFIED SURGICAL PROCEDURE, PROLONGED SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14712245 ↗InjuryFeb 14, 2022Material Twisted/Bent; Material Twisted/Bent
DAMAGED HAPTIC AFTER IMPLANTATION. THE HAPTIC WAS NOTED TO BE BENT DURING INSERTION. THE INCISION ENLARGEMENT WENT FROM A 2.7MM TO 3.0MM TO REMOVE THE LENS. PATIENT CONDITION: FAILURE OF IMPLANT. HEALTH IMPACT: DEVICE EXPLANTATION.
Patient problems: Failure of Implant
MAUDE report 13529364 ↗MalfunctionJan 11, 2021Material Twisted/Bent; Material Twisted/Bent
(B)(6) 2020 : INITIAL COMPLAINT REPORTED BY DISTRIBUTOR INDICATED: DEFORMED HAPTIC AFTER IMPLANTATION; INTRA-OPERATIVE EXPLANT. NO INCISION ENLARGEMENT OR SUTURES WERE NECESSARY; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED. 04-JAN-2020: ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR REPORTED: THE ACCOUNT HAS INDICATED THE PATIENT IS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11149284 ↗
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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