iSert Intraocular Lens 251 (yellow), +25.50DRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547480450407), received between Jun 3, 2016 and Jan 5, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn1
- Sharp Edges1
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2026Sharp Edges
EVENT OCCURRED IN CHINA. POSTERIOR CAPSULE RUPTURE AFTER IMPLANTING THE IOL INTO THE CAPSULAR BAG ON (B)(6), A POSTERIOR CAPSULE RUPTURE WAS OBSERVED. UPON REPEATED REVIEW OF THE SURGICAL VIDEO, IT WAS SUSPECTED THAT THE HAPTIC TORE THE POSTERIOR CAPSULE. IN THIS CASE, THE RUPTURE WAS EXTENSIVE. ONE WEEK AFTER SURGERY, SIGNIFICANT IOL DISLOCATION WAS NOTED, AND ON NOVEMBER 13, AN IOL REPOSITIONING SURGERY WAS PERFORMED. THE IOL IS CURRENTLY IN PLACE, INTRAOCULAR PRESSURE IS NORMAL, AND THE PATIENT WILL CONTINUE TO BE CLOSELY MONITORED. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT; PATIENT HAS RECOVERED AND IS FINE; RELPOSITIONING SURGERY PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Insufficient Information
MAUDE report 23967928 ↗MalfunctionJun 3, 2016Material Split, Cut or Torn
TORN HAPTIC WAS REPORTED DURING IOL INSERTION. THE TRAILING HAPTIC WAS STUCK IN THE INTRODUCER. THE IOL WAS STILL USED. PATIENT OUTCOME IS UNKNOWN AT THIS TIME. THE LENS WAS NOT EXPLANTED
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5698387 ↗
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