OrthoviscRecalls & reported problems across all models

We found 2 models of Orthovisc by Anika Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2016 and Feb 26, 2026 — classified as 2 deaths, 39 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Orthovisc problems

Orthovisc models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Orthovisc 630-254

  Acid, Hyaluronic, Intraarticular
  2 deaths40 reports
• Orthovisc 630254

  Acid, Hyaluronic, Intraarticular
  5 reports

Recent Orthovisc adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJul 7, 2021No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  THE FDA REPORTED THE FOLLOWING WHICH WAS REPORTED TO THE FDA ON MW5101384 BY A CLINIC. THE DOCTORS OFFICE CALLED IN A NEW PRESCRIPTION FOR ORTHOVISC FOR ILATERAL KNEE FOR FOUR WEEKS. THE DOCTOR IS AWARE THAT THIS IS OFF-LABEL DOSING AND WANTS TO CONTINUE. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127295 ↗
• MalfunctionJul 6, 2021Patient-Device Incompatibility

  A PATIENT REPORTED THE FOLLOWING TO THE FDA ON MW5101325: PATIENT EXPERIENCED A RASH ON THE BODY AND REPORTED LESIONS ON THE SKIN IN THE THIGH AREA. ITCHING WAS ALSO REPORTED. PATIENT SAW A DERMATOLOGIST AN NEUROLOGIST AND REPORTS USING A UNSPECIFIED CREAM TO TREAT. ADDITIONAL INFORMATION WAS SOLOCITED. SEE H10 FOR ADDITIONAL INFORMATION.

  Patient problems: Itching Sensation; Rash

  MAUDE report 12125567 ↗
• InjuryMar 1, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  BEGAN SWELLING WHOLE LEFT LEG (B)(6) 2020, WENT TO DOCTOR (B)(6) 2020 DUE TO INCREASE SWELLING. DUE TO COMPLICATION FROM INJECTION AND NECESSARY ASPIRATION AND SURGERY, I HAVE INCREASE IMMOBILITY IN LEG. PATIENT REPORTED 2 ASPIRATION. I ORTHOVISC SURGERY WITH OVERNIGHT HOSPITAL STAY.

  Patient problems: Arthralgia; Arthritis; Swelling/ Edema

  MAUDE report 11394878 ↗
• InjuryJan 8, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT VIA PHONE THAT HE RECEIVES 3 INJECTIONS EVERY YEAR, BUT AFTER A FORTH KNEE INJECTION IN SEPTEMBER, PATIENT CAN BARELY WALK. A COUPLE OF WEEKS AFTER THE INJECTION, THE PATIENT REPORTED KNEE PAIN THAT DEVELOPED TO LEG PAIN, FINALLY TO HIP PAIN WITH INFLAMMATION. THE PATIENT HAS GONE THRU BLOOD TESTS WITH CLEAN RESULTS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Arthralgia; Insufficient Information; Pain

  MAUDE report 11140794 ↗
• DeathOct 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY MEDICARE IVR VIA EMAIL THAT THE PATIENT PASSED AWAY. IT WAS CONFIRMED THAT THE PATIENT HAS BEEN ON ORTHOVISC MEDICATION SINCE 2013. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 10740610 ↗
• InjuryMar 25, 2020Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT ASSISTANCE GROUP THAT PATIENT STATED SHE IS WAITING FOR A KNEE REPLACEMENT AND NEEDS TO USE THE ORTHOVISC. SHE GOT A DOUBLE BLOOD CLOT AND HAD TO GO TO THE HOSPITAL WHERE SHE RECEIVED PHARMACOLOGICAL TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Disseminated Intravascular Coagulation (DIC); Embolus

  MAUDE report 9881114 ↗
• InjuryFeb 6, 2020Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ON 15 JANUARY 2020, (B)(6) FROM (B)(6) CALLED ANIKA TO REPORT THAT SHE WAS EXPERIENCING POSSIBLE ALLERGIC REACTION TO AN ORTHOVISC INJECTION AND IT WAS PROVOKED IN HER KNEE. THE SAME REPORTS WAS RECEIVED FROM THIS PATIENT THROUGH THE FDA MEDWATCH REPORT MW5092019. ON 29 JANUARY 2020, PATIENT PROVIDED ADDITIONAL INFORMATION ON THIS CASE. PATIENT REPORTED HAVING THE ORHOVISC TREATMENT ON (B)(6) 2019 AND ON (B)(6), EXPERIENCE ALLERGIC REACTION (HIVES AND RASHES OVER ENTIRE BODY, SWELLING OF FEET, KNEES, AND CALVES, AND TOES WITH CLEAR LIQUID). PATIENT REPORTED REFUSING THE THIRD INJECTION DUE TO THESE ALLERGIC REACTIONS. PATIENT REPORTED SHE HAD IN THE PAST USED SUPARTZ TREATMENT EVERY SIX MONTHS FOR SEVERAL DECADES BECAUSE SHE NO LONGER HAVE MENISCUS IN EITHER KNEE. PATIENT REPORTED NEVER EXPERIENCING ALLERGIC REACTION AFTER SUPARTZ TREATMENT.

  Patient problems: Edema; Patient Problem/Medical Problem; Swelling

  MAUDE report 9678106 ↗
• InjuryJan 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  WORSENING PAIN IN THE RIGHT KNEE. THE 1ST INJECTION AND 2ND INCREASED PAIN. AFTER 3RD INJECTION HAD SEVERE PAIN AND INCREASED SWELLING. TWO WEEKS LATER, HAD TO GET CORTISONE INJECTION TO DECREASE SWELLING AND PAIN WHICH HAD NO EFFECT. HAD TO TAKE PAIN MED EVERY 6 HRS. WHICH JUST DULLED THE PAIN. HAD PROBLEMS WITH SLEEPING, WALKING. DR( B)(6) STATED MORE THAN ½ OF PTS HAVE MORE PAIN WITH THE INJECTION. HAD EUFLEXXA INJECTION WITH NO PROBLEMS. AFTER 3RD INJECTION, SOLUTION FELT LIKE A HARD ROCK UNDER THE KNEECAP. STILL HAVING MORE PAIN THAN I DID BEFORE THE INJECTION.

  Patient problems: Arthralgia; Joint Swelling

  MAUDE report 9592774 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS REPORTED BY CONSUMER AND CONCERN (B)(6) YEARS OLD CAUCASIAN FEMALE WHO EXPERIENCE THYROID CANCER, SWALLOWING DIFFICULTIES, RINGING IN HER EARS, COUGHING PROFUSELY, DIZZINESS, VERTIGO, TERRIBLE REACTION TO ORTHOVISC, TRIGLYCERIDES INCREASE AND UNDERDOSE, COINCIDENT WITH VASCEPA. IN 2016 ( REPORTED AS THREE YEARS AGO) THE PATIENT INITIATED VASCEPA, 2 CAPSULES TWICE DAILY, ORAL FOR HYPERTRIGLYCERIDEMIA. IN 2018 ( REPORTED AS ONE YEAR AGO) THE DOSE WAS REDUCED TO 1 CAPSULE TWICE DAILY. (CURRENT LOT NUMBER 7K02784 AND EXPIRATION DATE SEP 2021). IT WAS NOT REPORTED WHETHER THE DOSE REDUCTION WAS INITIATED BY THE PATIENT OF THE PHYSICIAN. MEDICAL HISTORY WAS RELEVANT FOR ARTHRITIS AND HIGH CHOLESTEROL. CONCOMITANT MEDICATION WERE CRESTOR (ROSUVASTATIN), RHEUMATE, (FOLATE, METHYLCOBALAMIN, CURCUMINOID TURMERONE COMPLEX), CELEBREX (CELECOXIB), TIZANIDINE AND GELSYN (HYDRAULIC ACID. SHE HAS AN ALLERGY TO TETRACYCLINE. SHE IS A NON-SMOKER AND DRINKS RED WINE 4-5 TIMES A WEEK. IN (B)(6) 2019, THE PATIENT EXPERIENCED SWALLOWING DIFFICULTIES, RINGING IN HER EARS, COUGHING PROFUSELY, DIZZINESS, VERTIGO AND HIGH BLOOD PRESSURE. A BIOPSY IN HER TH

  Patient problems: Dizziness; Thyroid Problems; Vertigo

  MAUDE report 9121464 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  I WAS PRESCRIBED BY MY DOCTORS OF THE (B)(6) ORTHOPEDICS GROUP YOUR ORTHOVISC TO EASE MY ARTHRITIS PAIN ON MY KNEE. BEFORE THE INJECTION, I WAS WALKING WITHOUT A CAIN OR ANY ASSISTANCE, LIVE IN MY HOUSE ENJOYING MY GOLDEN YEARS GOING SWIMMING WITH FRIENDS WITH A LITTLE PAIN ON MY KNEE. AFTER THE INJECTIONS 3 TO EACH KNEE, THE PAIN IS UNBELIEVABLY UNBEARABLE. I'VE CALLED MY INSURANCE HUMANA; THE PHARMACIST TOLD ME MAYBE 3 TIMES WAS NOT ENOUGH SO THE DOCTOR PRESCRIBED TWO MORE. FINALLY, I'VE BEEN INJECTED 3 ON THE LEFT & 5 ON THE RIGHT KNEE. 2½ MONTHS LATER, I AM CONFINED TO BED WAITING FOR ASSISTANCE EVEN TO GO TO THE RESTROOM. I CANNOT WALK EVEN WITH WALKER. I AM NOT ALLERGIC TO BIRD PRODUCTS; I DO NOT HAVE ANY SKIN INFECTIONS OR DISEASES. YOUR INJECTIONS MESS ME UP BIG TIME. MY PCP ORDERED A MRI TO DETERMINE THE CATASTROPHE OF MY KNEES. I DID IT ON (B)(6) 2019. UP TO NOW MY COPAY FOR MY INSURANCE THE DOCTOR JUST FOR THE INJECTION IS $1000 WITHOUT COPAY FOR DOCTORS MRI AND ASSISTANCE. I CAN'T SLEEP AT NIGHT FROM PAIN. THIS IS A FRIENDLY NOTICE FROM ME TO YOU. I NEED YOUR HELP IN MANY WAYS. IF YOU ALL HAVE AN ANTIDOTE, I HAVE TO HAVE IT. I NEED YOUR HELP TO PAY ALL OF THESE BILLS. I

  Patient problems: No Code Available; Pain

  MAUDE report 8311988 ↗

Other Anika Therapeutics, Inc. products

• Monovisc2 models · 38 reports