iSert Intraocular Lens 251 (yellow), +20.00DRecalls & 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 04547480450292), received between May 17, 2016 and Jun 28, 2023 — 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.
Most reported problems
Device problems
- Break1
- Defective Device1
- Device Dislodged or Dislocated1
- Material Split, Cut or Torn1
Patient problems
- Failure of Implant1
- No Known Impact Or Consequence To Patient1
- Rupture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN VIETNAM. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. OVD USED WAS REPORTED AS "UNKNOWN." DAMAGED HAPTIC AFTER IMPLANTATION. PROBLEM CODE: A0414 MATERIAL SPLIT, CUT OR TORN. IMPLANT DATE: (B)(6)2020. EXPLANT DATE: (B)(6)2020. PATIENT IMPACT: DEVICE EXPLANTATION.
Patient problems: Failure of Implant
MAUDE report 17218180 ↗InjuryMay 3, 2019Break; Break
ONCE THE IOL WAS INJECTED INTO THE CAPSULA BAG IT WAS NOTICED THAT THE TRAILING HAPTIC WAS DETACHED FROM THE OPTIC. SURGEON HAD TO MAKE A BIGGER INCISION AND USE IOL CUTTER THE LENS THAT WAS ALREADY INSIDE THE CAPSULA BAG. A NEW LENS WAS OPENED AND USED SUCCESSFULLY; SURGEON DID NOT HAVE TO SUTURE THE INCISION AS THERE WAS NO VITREOUS LEAK HAPPENING AFTER SHE ASSESSED THE EYE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8579883 ↗InjuryMay 17, 2016Defective Device; Device Dislodged or Dislocated
DURING THE LENS IMPLANTATION STEP, THE DEFECTIVE FUNCTIONING OF THE DEVICE CAUSED THE POSTERIOR CAPSULE RUPTURE AND THE DISLOCATION OF THE LENS IN THE VITREOUS CHAMBER. PATIENT OUTCOME IS UNKNOWN AT THIS TIME. THE LENS WAS EXPLANTED AND A YA-60BBR WAS IMPLANTED.
Patient problems: Rupture
MAUDE report 5660360 ↗
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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