iSert Intraocular Lens 250 (clear), +24.00DRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547480480862), received between Mar 22, 2017 and Dec 28, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Crack” (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
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Entrapment of Device1
- Inaccurate Information1
Patient problems
- Capsular Bag Tear1
- Injury1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
- Vitreous Loss1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 28, 2023Crack; Crack
DAMAGED OPTIC AFTER IMPLANTATION/POST-OPERATIVE COMPLICATIONS. THE IMPLANTED IOL HAD A SCRATCH AND THE PATIENT COMPLAINED UNUSUAL FOR THEIR VISION AFTER THE OPERATION. THE DOCTOR DID NOT NOICE THE SCRATCH OF THE IOL DURING THE OPERATION, BUT AFTER THE SURGERY THE DOCTOR CONFIRMED THE SCRATCH ON THE IOL. THE IOL WAS EXPLANTED FROM THE PATIENT EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18412544 ↗InjurySep 12, 2019Inaccurate Information; Inaccurate Information
INCORRECT INFORMATION ON LABEL~THIS IS JUST ONE POSSIBILITY. AFTER IMPLANTING THE 24.00 D. IOL THE PATIENT ENDED UP IN 4.00 D. HYPERCORRECTION. BIOMETRIES BEFORE AND AFTER SURGERY ARE CONSISTENT. THE LENS WAS EXPLANTED. SECONDARY SURGERY WAS DONE ON (B)(6) 2019. A NEW LENS WAS INSERTED WITHOUT ANY PATIENT HARM. AFTER SECOND SURGERY PATIENT FEELS GOOD.
Patient problems: Visual Impairment
MAUDE report 9014663 ↗InjuryJul 28, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VITREOUS LEAK AND A SPILT IN THE POSTERIOR CAPSULE WHEN THE LENS WAS INSERTED. THE LENS WAS CUT OUT OF THE BAG AND ANOTHER LENS MODEL WAS PLACED IN THE SULCUS. IN THE SURGEON'S OPINION, THE LIKELY CAUSE OF THE EVENT WAS "SPILT IN CAPSULE BAG."
Patient problems: Capsular Bag Tear; Vitreous Loss
MAUDE report 6750665 ↗InjuryMar 22, 2017Entrapment of Device
IT WAS REPORTED WHILE DOCTOR WAS ADVANCING THE LENS, IT STUCK IN THE INJECTOR. THE INJECTOR/LENS WAS REMOVED AND THE INCISION WAS ENLARGED. A BACK-UP LENS WAS IMPLANTED WITH NO ISSUE. PATIENT'S OUTCOME IS GOOD.
Patient problems: Injury
MAUDE report 6424840 ↗
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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