Orthovisc 630254Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00817337000111), received between Oct 12, 2023 and Feb 26, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY (B)(6) OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, (B)(6), OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED IN THIS REPORT. ON 11FEB2026, THE DISTRIBUTOR REPORTED THE FOLLOWING TO ANIKA: WE RECEIVED AN ANIKA PRODUCT COMPLAINT WITH THE FOLLOWING EVENT DESCRIPTION AS REPORTED TO J&J MEDTECH ORTHOPEDICS ON 09-FEB-2026. EVENT DATE WAS 04APR2025. (B)(6) 2 ML US - 630254: LOT NUMBER UNKNOWN. THE DEVICE RETURN IS UNKNOWN. EVENT DESCRIPTION: PATIENT STATES THAT HE HAS ORTHOVISC IN THE PAST WITHOUT DIFFICULTY OR REACTION. PATIENT HAD ORTHOVISC IN BOTH KNEES. AFTER RECEIVING THE 3RD INJECTION, THE RIGHT KNEE WAS EXTREMELY SWOLLEN AND PAINFUL. PATIENT REPORTS THAT HIS LOWER RIGHT EXTREMITY - FROM KNEE DOWN TO FOOT BEGAN TURNING COLORS. PHYSICIAN WENT AHEAD AND GAVE THE 4TH INJECTION. PATIENT STATES THAT HE BEGAN HAVING JOINT PAIN IN BILATERAL KNEES, HIPS AND SHOULDERS AND HE HAS BEEN TO MANY DOCS AND BEEN TESTED FOR EVERYTHING AND DOCS ARE NOT ABLE TO MAKE DIAGNOSIS. HE HAD THE RIGHT KNEE DRAINED TWICE AND

  Patient problems: Arthralgia; Cyanosis; Limb Pain; Swelling/ Edema

  MAUDE report 24460661 ↗
• MalfunctionDec 29, 2025Component Missing; Component Missing

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY (B)(6) OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, (B)(6), OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED IN THIS REPORT. ON 09DEC2025 MEDSUN MDR REPORT 3500A (B)(4) WAS RECEIVED BY (B)(6). IT WAS REPORTED THAT THE BLUE FLANGE PART OF THE SYRINGE FOR 3 ORTHOVISC INJECTABLES WERE MISSING WHEN THE PACKAGING WAS OPENED. PN 630254 LOT NUMBER: 0000011003 EXPIRATION DATE: 15NOV2026. DEVICE NOT AVAILABLE FOR RETURN. COMPLAINANT OFFICE BECAME AWARE OF THE ISSUE MAY 2025. OFFICE DID NOT OBTAIN A PICTURE OF THE SYRINGE MISSING THE FLANGE. THE OFFICE STAFF DID NOT NOTE ANY UNUSUAL APPEARANCES TO THE DEVICE (BESIDES MISSING THE BLUE FLANGE). THERE WAS NO DEFECT WITH THE DEVICE OR PACKAGING OBSERVED PRIOR. THERE WAS NO NEGATIVE PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23910626 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED IN THIS REPORT. ON (B)(6) 2025, IT WAS REPORTED TO ANIKA THAT AFTER RECEIVING AN ORTHOVISC INJECTION, THE PATIENT HAD A PSEUDOSEPTIC REACTION TO ORTHOVISC. THE PATIENT'S KNEE WAS THEN ASPIRATED AND TESTED POSITIVE FOR STREPTOCOCCOUS MITIS ORALIS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THERE WAS NO MALFUNCTION REPORTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION IS BEING SOLICITED.

  Patient problems: Arthritis; Bacterial Infection; Hypersensitivity/Allergic reaction

  MAUDE report 23329798 ↗
• MalfunctionJan 14, 2025Break; Break

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 19DEC2024 THE DISTRIBUTOR REPORTED THAT A ORTHOVISC SYRINGE BROKE DURING THE INJECTION. IT WAS INDICATED THAT THE BREAK OCCURRED AT THE LUER LOCK LOCATION OF THE GLASS SYRINGE. THERE WAS NO NEGATIVE PATIENT OR USER IMPACT REPORTED. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150644 ↗
• InjuryOct 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 15 SEPT 2023 ANIKA RECEIVED A MEDWATCH REPORT (MW514271) FROM THE FDA. IT WAS REPORTED ON THE MEDWATCH THAT A PATIENT REPORTED HAVING A LEFT KNEE REPLACEMENT SURGERY ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT THE PATIENT HAD ONE INJECTION INTO THE LEFT KNEE ONCE A WEEK, ON AN UNSPECIFIED DATE(S). ORTHOVISC WAS LISTED AS THE PRODUCT IN THE MEDWATCH REPORT. THE MEDWATCH REPORT WAS MARKED AS AN ADVERSE EVENT. HOWEVER, THERE WAS NO SPECIFIC ADVERSE EVENT REPORTED FOR THE ORTHOVISC INJECTION(S). IT WAS NOT REPORTED IF THE PATIENT IS ALLEGING A TEMPORAL ASSOCIATION BETWEEN THE USE OF ORTHOVISC AND THE PATIENT'S LEFT KNEE REPLACEMENT. THE PHARMACY WHO REPORTED THE MEDWATCH WAS CONTACTED AND WHEN ADDITIONAL INFORMATION WAS SOLICITED, RESPONDED THAT THE PATIENT DID NOT PROVIDE ANY CONSENT TO FOLLOW UP. THE PATIENT ALSO DID NOT ALLEGE THE ORTHOVISC DEVICE(S) INJECTIONS WAS

  Patient problems: Insufficient Information

  MAUDE report 17922702 ↗