IPure B1PY (yellow), +19.50DRecalls & reported problems
Hoya Medical Singapore Pte. Ltd. · Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use. · Class 3 · Implant
All models of IPure (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886158017684), received between Dec 20, 2023 and Jan 9, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
COMPLAINT REFERENCE (B)(4). DAMAGED HAPTIC AFTER IMPLANTATION. IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN. LEADING HAPTIC BROKE OFF UPON INSERTION IOL NEEDED TO BE CUTOUT OF PATIENTS EYE AND ANOTHER B1PY WAS SUCCESSFULLY IMPLANTED BY THE SURGEON (B)(6) TO THE PATIENT. IOL WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 18476318 ↗InjuryDec 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN. LEADING HAPTIC BROKE OFF UPON INSERTION IOL NEEDED TO BE CUTOUT OF PATIENTS EYE AND ANOTHER B1PY WAS SUCCESSFULLY IMPLANTED BY THE SURGEON NOHARM TO THE PATIENT IOL WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 18369675 ↗
Other Intraocular Lens devices
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- 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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