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Amvisc Plus 655-806Recalls & reported problems

Anika Therapeutics, Inc. · 0.8 ml, 1.6% Sodium Hyaluronate · 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 07391899830605), received between Aug 11, 2017 and Aug 11, 2017 — 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

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryAug 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE AMVISC TIP SHOT OUT DURING A PROCEDURE AND HIT THE PATIENT IN THE EYE. THE FACILITY INDICATED THAT THEY WOULD BE FILING A MEDWATCH REPORT. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 03/31/2017. THE FACILITY STATED THAT THE TIP SHOT OUT AS A RESULT OF THE SYRINGE BURST WHILE ATTEMPTING TO APPLY VISCOELASTIC. THE TIP HIT THE PATIENT IN THE LEFT EYE ZONULE AREA AND THE SURGEON CANCELED THE SURGERY, GIVEN THAT HE NO LONGER BELIEVED THE ZONULES COULD SAFELY HOLD THE IOL. THE PATIENT WAS ADVISED TO COME BACK THE FOLLOWING DAY AND WAS TOLD THAT THEY'D ALSO BE GETTING REFERRED TO A RETINAL SPECIALIST FOR THE INJURY.

    Patient problems: No Code Available

    MAUDE report 6789701 ↗

Other Aid, Surgical, Viscoelastic devices

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