NuVisc 600-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30886158020067), received between Aug 10, 2017 and Aug 24, 2017 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTS THAT THE SURGEON WAS INJECTING NUVISC INTO THE ANTERIOR CHAMBER OF THE PATIENT AND THE NUVISC CAME OUT OF THE SYRINGE FROM UNDER THE HUB AND THE CANNULA CAME OFF RESULTING IN A TORN CAPSULE.

  Patient problems: Eye Injury

  MAUDE report 6816854 ↗
• InjuryAug 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL REPORT CAME IN ON (B)(6) 2016 AS A VOICEMAIL: THE VOICEMAIL STATED; "WE RECENTLY HAD A COMPLAINT ABOUT THIS PRODUCT CAUSING INFLAMMATION. I AM CALLING TO SEE HOW BEST TO GO ABOUT INVESTIGATING THIS COMPLAINT." ORIGINAL CASE WAS CLOSED, BUT NEW INFORMATION WAS RECEIVED ON THE (B)(6) 2017 INFORMING US OF A REPORTABLE EVENT. NEW INFORMATION: PATIENT DEVELOPED ENDOPHTHALMITIS. THE CONDITION WAS TREATED WITH AN INJECTION OF UNKNOWN MEDICATION. PATIENT ISSUE WAS REPORTED TO HAVE RESOLVED IN A REASONABLE AMOUNT OF TIME.

  Patient problems: Eye Injury

  MAUDE report 6786474 ↗
• InjuryAug 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL REPORT CAME IN ON (B)(6) 2016 AS A VOICEMAIL: THE VOICEMAIL STATED; "WE RECENTLY HAD A COMPLAINT ABOUT THIS PRODUCT CAUSING INFLAMMATION. I AM CALLING TO SEE HOW BEST TO GO ABOUT INVESTIGATING THIS COMPLAINT." ORIGINAL CASE WAS CLOSED, BUT NEW INFORMATION WAS RECEIVED ON THE (B)(6) 2017 INFORMING US OF A REPORTABLE EVENT. NEW INFORMATION: PATIENT DEVELOPED ENDOPHTHALMITIS. THE CONDITION WAS TREATED WITH AN INJECTION OF UNKNOWN MEDICATION. PATIENT ISSUE WAS REPORTED TO HAVE RESOLVED IN A REASONABLE AMOUNT OF TIME.

  Patient problems: Eye Injury

  MAUDE report 6786470 ↗

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-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-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-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