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Synergetics BL5240Recalls & reported problems

Synergetics USA, Inc. · Entry Site Alignment System with Valve · Class 1

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 10841305111360), received between Jun 29, 2018 and Jun 29, 2018 — 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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Endophthalmitis1

Recent adverse event reports

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

  • InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE PATIENT DEVELOPED ENDOPHTHALMITIS AFTER A PROCEDURE IN WHICH BAUSCH + LOMB DEVICES WERE USED. THE CAUSE OF THE ENDOPHTHALMITIS HAS NOT BEEN DETERMINED. ADDITIONAL INFORMATION REGARDING POSSIBLE TREATMENT AND PATIENT OUTCOME HAS BEEN REQUESTED.

    Patient problems: Endophthalmitis

    MAUDE report 7650686 ↗

Other Cannula, ophthalmic devices

All Cannula, ophthalmic devices →

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