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Bausch + Lomb BL5115-1Recalls & reported problems

Bausch & Lomb Incorporated · Adaptive Fluidics Premium Pack · Class 2

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 10757770058836), received between Jan 10, 2024 and Jan 10, 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: 1 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: 0 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

  • Abscess1
  • Endophthalmitis1
  • Eye Burn1

Recent adverse event reports

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

  • InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE USER FACILITY IN FRANCE REPORTED THAT DURING THE PROCEDURE THE PATIENT HAD A CORNEAL BURN, CORNEAL HEALING DEFECT, SEIDEL AND CHOROIDAL DETACHMENT DUE TO HYPOTONIA. SUTURES WERE PLACED AND THE DURATION OF SURGERY WAS INCREASED BY 0-15 MINUTES. DURING POST-OP, THE PATIENT PRESENTED WITH SUSPICION OF ENDOPHTHALMITIS AND WAS BEING CARED FOR AT A HOSPITAL. CORNEAL ABSCESS CAUSED BY SUTURES AT THE SITE OF THE CORNEAL BURN ALSO OCCURRED.

    Patient problems: Abscess; Endophthalmitis; Eye Burn

    MAUDE report 18489581 ↗

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