Anikavisc 600-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00866142000045), received between Aug 13, 2018 and Jul 24, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

4 other recalls cover devices cleared under the same FDA submission (P000046); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2020Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  CANNULA DISLODGED DURING USE IN CATARACT SURGERY AND HIT PATIENT'S EYE, REQUIRING AN ANTERIOR VITRECTOMY. TECH AND SURGEON STATE CANNULA WAS SCREWED ON TIGHTLY. IT WAS REPORTED THAT PATIENT WAS IN STABLE CONDITION.

  Patient problems: Eye Injury

  MAUDE report 10321132 ↗
• InjuryAug 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGERY THE CANNULA POPPED OFF THE SYRINGE AND WENT THROUGH THE IRIS OF THE PATIENT. IT IS REPORTED TO NOT HAVE CAUSED PERMANENT DAMAGE.

  Patient problems: Eye Injury; Pain

  MAUDE report 7778759 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000046. One submission often covers many models, so check the product and lot details in each record.

• Z-1106-05 · Jul 18, 2005 · Terminated
  Staarvisic II Sodium Hyaluronate, 0.8 mL
• Z-1383-05 · Jul 14, 2005 · Terminated
  ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC
• Z-1382-05 · Jul 14, 2005 · Terminated
  Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CA
• Z-0109-04 · Oct 8, 2003 · Terminated
  Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CA