Medline Industries, Inc. VAL011CTASARecalls & reported problems
Medline Industries, Inc. · CATARACT PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10889942021376), received between Jan 4, 2019 and Jan 4, 2019 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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, 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
- Device Contamination with Chemical or Other Material4
- Material Fragmentation2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Foreign Body In Patient8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJan 4, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING THE POST-OPERATIVE EVALUATION OF A PATIENT, AFTER AN UNIDENTIFIED PROCEDURE, BLUE FIBERS WERE FOUND IN THE PATIENT'S EYE.
Patient problems: Foreign Body In Patient
MAUDE report 8219073 ↗InjuryJan 4, 2019Insufficient Device Problem Information
IT WAS REPORTED THAT DURING THE POST-OPERATIVE EVALUATION OF A PATIENT, AFTER AN UNIDENTIFIED PROCEDURE, BLUE FIBERS WERE FOUND IN THE PATIENT'S EYE.
Patient problems: Foreign Body In Patient
MAUDE report 8219029 ↗InjuryJan 4, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING THE POST-OPERATIVE EVALUATION OF A PATIENT, AFTER AN UNIDENTIFIED PROCEDURE, BLUE FIBERS WERE FOUND IN THE PATIENT'S EYE.
Patient problems: Foreign Body In Patient
MAUDE report 8218886 ↗InjuryJan 4, 2019Material Fragmentation
IT WAS REPORTED THAT DURING THE POST-OPERATIVE EVALUATION OF A PATIENT, AFTER AN UNIDENTIFIED PROCEDURE, BLUE FIBERS WERE FOUND IN THE PATIENT'S EYE.
Patient problems: Foreign Body In Patient
MAUDE report 8218661 ↗InjuryJan 4, 2019Material Fragmentation
IT WAS REPORTED THAT DURING THE POST-OPERATIVE EVALUATION OF A PATIENT, AFTER AN UNIDENTIFIED PROCEDURE, BLUE FIBERS WERE FOUND IN THE PATIENT'S EYE.
Patient problems: Foreign Body In Patient
MAUDE report 8218653 ↗InjuryJan 4, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING THE POST-OPERATIVE EVALUATION OF A PATIENT, AFTER AN UNIDENTIFIED PROCEDURE, BLUE FIBERS WERE FOUND IN THE PATIENT'S EYE.
Patient problems: Foreign Body In Patient
MAUDE report 8218438 ↗InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE POST-OPERATIVE EVALUATION OF A PATIENT, AFTER AN UNIDENTIFIED PROCEDURE, BLUE FIBERS WERE FOUND IN THE PATIENT'S EYE.
Patient problems: Foreign Body In Patient
MAUDE report 8218353 ↗InjuryJan 4, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING THE POST-OPERATIVE EVALUATION OF A PATIENT, AFTER AN UNIDENTIFIED PROCEDURE, BLUE FIBERS WERE FOUND IN THE PATIENT'S EYE.
Patient problems: Foreign Body In Patient
MAUDE report 8218275 ↗
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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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