PREVUE C PREVUE (clear), +23.00DRecalls & 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 PREVUE C (14)
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 10757770564214), received between Nov 8, 2022 and Sep 16, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Sharp Edges” (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
- Sharp Edges2
Patient problems
- Capsular Bag Tear2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2024Sharp Edges; Sharp Edges
EVENT OCCURRED IN USA. DEFECT IN THE IOL WITH A POOR SMOOTHNESS RESULTING IN RUPTURING THE POSTERIOR CAPSULE. CAPSULAR BAG TEAR / RUPTURE. PREVUE LENS CAUSED POSTERIOR CAPSULE TEAR UPON INSERTION IMMEDIATELY. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. ANTERIOR VITRECTOMY WAS REQUIRED. THE IOL WAS EXPLANTED INTRAOPERATIVELY. NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. CURRENT PATIENT PROGNOSIS IS GOOD. EXPLANTATION DATE: (B)(6) 2023. PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Capsular Bag Tear
MAUDE report 20233584 ↗InjuryNov 8, 2022Sharp Edges; Sharp Edges
INTRA-OPERATIVE COMPLICATIONS: LENS WAS IMPLANTED THEN EXPLANTED DUE TO LENS DECENTERED BECAUSE OF POSTERIOR CAPSULE TEAR.
Patient problems: Capsular Bag Tear
MAUDE report 15756451 ↗
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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
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- 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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