IPure B1PC (clear), +17.00DRecalls & 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
- 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 00886158017141), received between Mar 8, 2023 and Jun 7, 2023 — classified as 3 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 16, 2026.
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Device Handling Problem1
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 7, 2023Device Handling Problem; Device Handling Problem
PROBLEM CODE: DEVICE HANDLING PROBLEM. INJECTOR MALFUNCTION WAS REPORTED. IMPLANT DATE: (B)(6) 2023; EXPLANT DATE: (B)(6) 2023 REPORTED.
Patient problems: Failure of Implant
MAUDE report 17080634 ↗InjuryMar 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION. DOCTOR IMPLANTED NOTICE BROKEN TRAILING HAPTIC AND HAD TO EXPLANT LENS. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.
Patient problems: Failure of Implant
MAUDE report 16509123 ↗InjuryMar 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION DOCTOR IMPLANTED NOTICE BROKEN TRAILING HAPTIC AND HAD TO EXPLANT LENS. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.
Patient problems: Failure of Implant
MAUDE report 16509088 ↗
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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