PREVUE C PREVUE (clear), +19.00DRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770564139), received between Aug 10, 2021 and Jan 8, 2023 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Material Split, Cut or Torn1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION. IT WAS REPORTED THAT LENS WAS IMPLANTED ON (B)(6) 2022 AND WAS EXPLANTED SAME DAY DUE TO BROKEN HAPTIC, NO INCISION ENLARGEMENT, AND NO SUTURES REQUIRED. PATIENT HEALTH NOT IMPACTED.
Patient problems: Failure of Implant
MAUDE report 16118981 ↗MalfunctionAug 10, 2021Break; Break
DAMAGED HAPTIC AFTER IMPLANTATION. THE BLUE PMMA TIP OF THE LEADING HAPTIC HAD SHEARED; THE SHEARED BLUE PMMA LEADING HAPTIC DID NOT ENTER INTO THE EYE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; NO INCISION ENLARGEMENT OR SUTURES REQUIRED; PATIENT HEALTH NOT IMPACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12304983 ↗
Other Intraocular Lens devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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