IPure B1PC (clear), +22.50DRecalls & 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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886158017257), received between Sep 10, 2024 and Sep 10, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Sharp Edges” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Sharp Edges1
Patient problems
- Capsular Bag Tear1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2024Sharp Edges; Sharp Edges
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING; ROOT; HAPTICS ON DEVICE DUE TO PC TEAR RUPTURE DURING IOL IMPLANTATION. BROKEN HAPTIC DURING USE; LEADING HAPTIC DOES NOT FOLD AS PER IFU. HAPTIC STUCK TOOPTIC TEMPORARILY~ FINALLY HAPTIC IS SEPARATED. CAPSULAR BAG TEAR / RUPTURE. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT; PATIENT HEALTH NOT IMPACTED. PATIENT HAS RECOVERED AND IS FINE; LENS DEPLOYED AS NORMAL. PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Capsular Bag Tear
MAUDE report 20185616 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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