PREVUE CRecalls & reported problems across all models
Hoya Medical Singapore Pte. Ltd. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 14 models of PREVUE C by Hoya Medical Singapore Pte. Ltd. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between May 19, 2021 and Sep 16, 2024 — classified as 17 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PREVUE C problems
Device problems
- Material Split, Cut or Torn9
- Sharp Edges6
- Break2
- Crack1
- Failure to Fold1
- Material Twisted/Bent1
- Unintended Ejection1
Patient problems
- Failure of Implant16
- Capsular Bag Tear6
- No Clinical Signs, Symptoms or Conditions4
PREVUE C models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PREVUE C PREVUE (clear), +21.00DIntraocular Lens3 reports
- PREVUE C PREVUE (clear), +15.50DIntraocular Lens2 reports
- PREVUE C PREVUE (clear), +19.00DIntraocular Lens2 reports
- PREVUE C PREVUE (clear), +19.50DIntraocular Lens2 reports
- PREVUE C PREVUE (clear), +23.00DIntraocular Lens2 reports
- PREVUE C PREVUE (clear), +24.50DIntraocular Lens2 reports
- PREVUE C PREVUE (clear), +9.50DIntraocular Lens1 report
- PREVUE C PREVUE (clear), +16.00DIntraocular Lens1 report
- PREVUE C PREVUE (clear), +16.50DIntraocular Lens1 report
- PREVUE C PREVUE (clear), +17.00DIntraocular Lens1 report
- PREVUE C PREVUE (clear), +17.50DIntraocular Lens1 report
- PREVUE C PREVUE (clear), +18.00DIntraocular Lens1 report
- PREVUE C PREVUE (clear), +21.50DIntraocular Lens1 report
- PREVUE C PREVUE (clear), +22.50DIntraocular Lens1 report
Recent PREVUE C adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJun 7, 2023Crack; Crack
DAMAGED OPTIC AFTER IMPLANTATION IT WAS REPORTED THAT LENS BROKE ON INSERTION AND HAD TO BE CUT OUT.
Patient problems: Failure of Implant
MAUDE report 17080652 ↗InjuryJun 5, 2023Sharp Edges; Sharp Edges
INTRA-OPERATIVE COMPLICATIONS. CAPSULE RUPTURE, EXPLANTATION PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED.
Patient problems: Capsular Bag Tear; Failure of Implant
MAUDE report 17067452 ↗InjuryJun 5, 2023Sharp Edges; Sharp Edges
INTRA-OPERATIVE COMPLICATIONS. CAPSULE RUPTURE, EXPLANTATION WHILE INSERTING THE LENS, IT TORE THE CAPSULE. NO INCISION ENLARGEMENT; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED.
Patient problems: Capsular Bag Tear; Failure of Implant
MAUDE report 17067451 ↗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 ↗InjuryMay 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION LENS WAS INSERTED INTO THE PATIENT'S EYE THEN NEEDED TO BE TAKEN OUT BECAUSE THE HAPTIC BROKE AND WAS STUCK IN THE PLUNGER. INCREASED INCISION SIZE; NO SUTURES WERE NEEDED; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; NO SUTURES WERE NEEDED; PATIENT HEALTH NOT IMPACTED.
Patient problems: Failure of Implant
MAUDE report 17015292 ↗InjuryMar 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
BROKEN HAPTIC DURING USE TRAILING HAPTIC BROKE DURING INSERTION. THE LENS WAS REMOVED, AND A BACKUP LENS PLACED WITHOUT ISSUES. PATIENT IMPACT: INTRA-OPERATIVE EXPLANTATION. PATIENT HEALTH NOT IMPACTED.
Patient problems: Failure of Implant
MAUDE report 16509078 ↗MalfunctionFeb 9, 2023Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT THE LENS ADVANCED TOO SOON, INJECTOR TOUCHED THE EYE. THE LENS CAME OUT BEFORE ENTERING THE EYE PRODUCT WAS REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT IMPACT: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16334279 ↗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 ↗InjuryJan 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION. LENS HAPTIC BROKE AFTER IMPLANTATION; BACK HAPTIC TORE OFF ON INSERTION REMAINED IN SHOOTER. THEY EXPLANTED THE LENS WITH THE INCISION ENLARGED AND NO SUTURES REQUIRED. PATIENT IMPACT: DEVICE EXPLANTATION PATIENT CURRENT PROGNOSIS: OUTCOME IS GOOD.
Patient problems: Failure of Implant
MAUDE report 16252947 ↗MalfunctionJan 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION. THE HAPTICS PUSHED OUT OF THE WAND AND THE LENS WAS NOT ABLE TO BE INSERTED, THE LENS WAS EXPLANTED DUE TO BROKEN HAPTIC. NO INCISION ENLARGEMENT; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; THE PROCEDURE WAS NOTCOMPLICATED IN ANY WAY. THE BACKUP IOL WAS SUCCESSFULLY IMPLANTED AND PATIENT OUTCOME IS GOOD. PATIENT HEALTH NOT IMPACTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16118998 ↗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 ↗InjuryJan 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION. HAPTIC BROKE OFF UNDER THE PLUNGER WHILE BEING DEPLOYED INCREASED INCISION SIZE; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; SUTURES WERE NOT REQUIRED; PATIENT HEALTH NOT IMPACTED.
Patient problems: Failure of Implant
MAUDE report 16118972 ↗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 ↗InjuryOct 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION. END OF HAPTIC BLUE PART BROKEN OFF IN INSERTER. LENS HAD TO BE REMOVED. INCISION WAS NOT ENLARGED AND NO SUTURES USED. PATIENT HEALTH NOT IMPACTED.
Patient problems: Failure of Implant
MAUDE report 15584493 ↗
Other Hoya Medical Singapore Pte. Ltd. products
All Hoya Medical Singapore Pte. Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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