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ClearVisc DVISC10Recalls & reported problems

Bausch & Lomb Incorporated · ClearVisc OVD 1.0 ML · Class 3

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00757770558360), received between Oct 3, 2024 and Oct 3, 2024 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Loss of Vision1
  • Toxic Anterior Segment Syndrome (TASS)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED ONE DAY POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT (OS) EYE, THE PATIENT EXPERIENCED SYMPTOMS THAT WERE LATER DIAGNOSED AS TASS. SLIT LAMP FINDINGS FOUND FIBRIN IN THE AC, AND THE PATIENT HAD A DECREASE IN VISION. A CULTURE WAS TAKEN. AN INTRAVITREAL STEROID INJECTION WAS ADMINISTERED TWO DAYS POST IMPLANT. THE RESULTS OF THE CULTURE AND SENSITIVITY WERE NEGATIVE. IN THE SURGEON'S OPINION, THE LIKELY CAUSE OF THE EVENT WAS THE IOL. THE PATIENT'S OUTCOME IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Vision; Toxic Anterior Segment Syndrome (TASS)

    MAUDE report 20359903 ↗

Other Aid, Surgical, Viscoelastic devices

All Aid, Surgical, Viscoelastic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.