IPure B1PC (clear), +22.00DRecalls & 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 00886158017240), received between Aug 10, 2021 and Sep 10, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
- Failure to Fold1
- Sharp Edges1
Patient problems
- Capsular Bag Tear3
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 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. WHEN HE WENT TO SPIN THE LENS INTO PLACE IT APPEARED THE HAPTICS TORE THE CAPSULE. ROOT; BROKEN HAPTIC DURING USE; HAPTIC DOES NOT FOLD AS PER IFU. CAPSULAR BAG TEAR / RUPTURE. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT. PATIENT HEALTH NOT IMPACTED. PATIENT HAS RECOVERED AND IS FINE. HE LEFT LENS IMPLANTED. BUT QUESTIONED WHETHER THE HAPTICS HAD CHANGED. LENS DEPLOYED AS NORMAL. WHEN HE WENT TO ROTATE THE HAPTICS TORE THE BAG. PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Capsular Bag Tear
MAUDE report 20185361 ↗InjurySep 12, 2023Failure to Fold; Failure to Fold
INTRA-OPERATIVE COMPLICATIONS: POSTERIOR CAPSULE RUPTURE, EXPLANTATION. LEAD HAPTIC UNFOLDED INFERIORLY AND BROKE THE BAG AND DOCTOR HAD TO PERFORM A VITRECTOMY. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT IMPACT: DEVICE EXPLANTATION.
Patient problems: Capsular Bag Tear; Failure of Implant
MAUDE report 17733639 ↗InjuryAug 10, 2021Break; Break
LEADING HAPTIC BROKE AND BROKE THE BAG POSTERIOR CAPSULE RUPTURE, PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; IMPLANTED IN SULCUS; PATIENT HAS RECOVERED AND IS FINE.
Patient problems: Capsular Bag Tear
MAUDE report 12304994 ↗
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- 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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