IPure B1PC (clear), +21.50DRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886158017233), received between Mar 23, 2022 and Jun 12, 2024 — classified as 3 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Break1
- Sharp Edges1
Patient problems
- Capsular Bag Tear1
- Failure of Implant1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING; TIP; DAMAGED HAPTIC; HAPTIC DOES NOT FOLD AS PER IFU; HAPTIC STUCK TO OPTIC TEMPORARILY~ FINALLY HAPTIC IS SEPARATED INCREASED INCISION SIZE; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED; PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525243 ↗MalfunctionJul 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION. SURGEON STATED AFTER IMPLANTING THE IOL INTO THE PATIENT'S EYE NOTICED THE FRONT HAPTIC WAS SHEARED OFF WHERE THE BLUE TIP OF THE HAPTIC MEETS CLEAR ACRYLIC. THE LENS WAS LEFT IMPLANTED IN PATIENT'S EYE. SURGEON WILL CONTINUE TO MONITOR FOR ROTATION.
Patient problems: Insufficient Information
MAUDE report 17375976 ↗InjuryApr 22, 2022Break; Break
AFTER LENS WAS IMPLANTED, DOCTOR SAW THE TRAILING HAPTIC WAS BROKEN OFF OF THE LENS. DOCTOR CUT THE LENS TO REMOVED IT WITHOUT INJURY. PATIENT IMPACT: EXPLANTATION.
Patient problems: Failure of Implant
MAUDE report 14181462 ↗InjuryMar 23, 2022Sharp Edges; Sharp Edges
INTRA-OPERATIVE COMPLICATIONS. POSTERIOR CAPSULE RUPTURE. DOCTOR REPORTED THAT SOMETHING HAPPENED IN THE PREPPING OF THE LENS OR IN THE INJECTOR THAT IS CUTTING THE LENS LEADING HAPTIC. THIS IS CREATING A SHARP EDGE THAT IS CAUSING THE POSTERIOR CAPSULE TO TEAR WHEN THE SHARP EDGE ON THE HAPTIC COMES IN CONTACT WITH IT. LENS STILL IN THE EYE VIA REVERSE OPTIC CAPTURE. PATIENT HAS RECOVERED AND IS FINE; PATIENT HAS 2020 AND 2030 UNCORRECTED.
Patient problems: Capsular Bag Tear
MAUDE report 13862667 ↗
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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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