iSert Intraocular Lens 250 (clear), +16.50DRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547480480718), received between Mar 28, 2017 and Feb 14, 2024 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Device Operates Differently Than Expected1
- Material Split, Cut or Torn1
Patient problems
- No Known Impact Or Consequence To Patient2
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN UNITED KINGDOM DAMAGED HAPTIC AFTER IMPLANTATION IMDRF CODE: A0414 - MATERIAL SPLIT, CUT, OR TORN BROKEN TRAILING HAPTIC DURING USE; TRAILING HAPTIC DOES NOT FOLD AS PER IFU PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18705533 ↗InjuryJun 11, 2019Break; Break
TORN HAPTIC - MUST BE EXPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8689710 ↗InjuryJun 11, 2019Break; Break
TORN HAPTIC - MUST BE EXPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8689706 ↗InjuryMar 28, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE LENS WENT THROUGH THE PATIENT'S POSTERIOR CAPSULE DURING IMPLANTATION. AS A RESULT, THE SURGEON MOVED THE LENS TO THE CENTER OF THE PUPILLARY SPACE AND THEN CUT/REMOVED IT IN PIECES. A VITRECTOMY WAS ALSO PERFORMED. BECAUSE THE SURGEON FELT THE CAPSULE WOULD NO LONGER SUPPORT A LENS, THE SURGERY WAS COMPLETED BY IMPLANTING A DIFFERENT LENS INTO THE SULCUS. THE PATIENT'S PROGNOSIS AFTER SURGERY IS EXCELLENT.
Patient problems: Failure of Implant
MAUDE report 6439782 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page