PREVUE C PREVUE (clear), +21.00DRecalls & 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
- 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 10757770564177), received between Oct 11, 2022 and May 26, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Fold” (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
- Failure to Fold1
- Material Twisted/Bent1
- Sharp Edges1
Patient problems
- Failure of Implant3
- Capsular Bag Tear1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2023Failure to Fold; Failure to Fold
DEFORMED HAPTIC AFTER IMPLANTATION SUSPECTED EXPLANTATION CASE. REPORTED BENT HAPTIC PRIOR TO LOADING. THERE WAS PATIENT CONTACT. NO PATIENT INJURY OR INCISION ENLARGEMENT. NO CLARIFICATION REGARDING TYPE OF PATIENT CONTACT AS OF (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 17015307 ↗InjuryFeb 8, 2023Sharp Edges; Sharp Edges
THE IOL WAS EXPLANTED INTRAOPERATIVELY FROM THE EYE DUE TO POSTERIOR CAPSULAR RUPTURE. THERE WERE NO ISSUE WITH THE LENS OR INJECTOR. NO SUTURES NEEDED AND NO INCISION ENLARGEMENT ANTERIOR VITRECTOMY WAS PERFORMED. ANOTHER IOL WAS IMPLANTED TO THE PATIENT EYE. PATIENT OUTCOME IS SATISFACTORY.
Patient problems: Capsular Bag Tear; Failure of Implant
MAUDE report 16320834 ↗InjuryOct 11, 2022Material Twisted/Bent; Material Twisted/Bent
DEFORMED HAPTIC AFTER IMPLANTATION. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; NO SUTURES WERE REQUIRED. A SECOND IOL WAS IMPLANTED SUCCESSFULLY; OUTCOME IS GOOD.
Patient problems: Failure of Implant
MAUDE report 15584486 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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