Amvisc Plus 60081LRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00757770495672), received between Aug 8, 2024 and Jun 18, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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, 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 11 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH CLINICAL FINDINGS CONSISTENT WITH ENDOPHTHALMITIS. AT THAT TIME, VISUAL ACUITY HAD DECREASED FROM 20/200 TO HAND MOTION. THE PATIENT WAS REFERRED THE SAME DAY TO A RETINA SPECIALIST, WHO DOCUMENTED 1-2 ANTERIOR CHAMBER CELLS, <1MM HYPOPYON, FIBRINOID MEMBRANE AT PUPIL, POSTERIOR SYNECHIAE, AND DENSE VITREOUS OPACITIES. A VITREOUS TAP WAS PERFORMED, AND INTRAVITREAL VANCOMYCIN AND CEFTAZIDIME WAS ADMINISTERED. THE CULTURE SHOWED NO GROWTH. IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN BID X 2 WEEKS (TOTAL DURATION: 1 MONTH) OFLOXACIN 0.3%: 1 GTT QID X 7 DAYS KETOROLAC 0.5%: 1 GTT QID X 2 WEEKS, THEN BID X 2 WEEKS (TOTAL DURATION: 1 MONTH) MEDICATIONS DOCUMENTED AT RETINA VISIT ON (B)(6) 2026: PREDNISOLONE ACETATE: 1% 1 GTT KETOROLAC 0.5%: 1 GTT TID OFLOXACIN 0.3%: 1 GTT QID CYCLOPENTOLATE 1%: 1 GTT TID.

  Patient problems: Endophthalmitis; Hypopyon; Visual Impairment; Vitreous Floaters

  MAUDE report 25551943 ↗
• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 2 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE, THE PATIENT PRESENTED WITH HYPOPYON AND VITRITIS. BASED ON THE FINDINGS, THE SURGEON CONCLUDED THE CAUSE AS ENDOPHTHALMITIS. IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDICATION ADMINISTERED DURING ORIGINAL SURGERY: INTRACAMERAL MOXIFLOXACIN. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH) OFLOXACIN 0.3%: 1 GTT QID X 7 DAYS KETOROLAC 0.5%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH)

  Patient problems: Endophthalmitis; Hypopyon

  MAUDE report 25551864 ↗
• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 6 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD) THE PATIENT PRESENTED WITH CLINICAL FINDINGS CONSISTENT WITH ACUTE ENDOPHTHALMITIS ACCOMPANIED BY A DECREASE IN VISUAL ACUITY FROM COUNTING FINGERS AT 4 FEET TO HAND MOTION. THE PATIENT WAS REFERRED THE SAME DAY TO A RETINA SPECIALIST, WHO PERFORMED A CULTURE AND ADMINISTERED AN INTRAOCULAR INJECTION. THE CULTURE SHOWED NO GROWTH. APPROXIMATELY EIGHT WEEKS LATER, THE PATIENT UNDERWENT A PARS PLANA VITRECTOMY TO ADDRESS A POSTERIOR VITREOUS DETACHMENT (PVD). AT THE POSTOPERATIVE VISIT THE FOLLOWING DAY, THE RETINA SPECIALIST DOCUMENTED: RESOLVED ACUTE ENDOPHTHALMITIS WITH STRUCTURALLY STABLE FINDINGS, CENTRAL RETINAL VEIN OCCLUSION WITH MACULAR EDEMA OD, EPIRETINAL MEMBRANE IN BOTH EYES (OU), RESOLVED PVD OD, AND PVD LEFT EYE (OS). IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE MOST RECENT RECORDED VISUAL ACUITY FOR THE AFFECTED EYE WAS NO LIGHT PERCEPTION (NLP). THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH) OFLOXACIN 0.3%

  Patient problems: Endophthalmitis; Macular Edema; Visual Impairment; Vitreous Detachment

  MAUDE report 25551570 ↗
• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 4 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE (OS), THE PATIENT PRESENTED COMPLAINING OF VISION LOSS AND EYE PAIN. SLIT LAMP EXAMINATION IDENTIFIED A FIBRIN REACTION WITH HYPOPYON. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS ENDOPHTHALMITIS. TWO DAYS LATER, THE PATIENT WAS EVALUATED BY A RETINA SPECIALIST WHO NOTED THE VIEW OF POSTERIOR SEGMENT WAS LIMITED DUE TO VITREOUS OPACITY. A VITREOUS TAP WAS PERFORMED, AND AN INJECTION OF VANCOMYCIN AND CEFTAZIDIME WAS ADMINISTERED. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) DECREASED TO HAND MOTION. IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PATIENT¿S OUTCOME IS UNKNOWN, AS THEY HAVE NOT RETURNED FOR FOLLOW-UP AND CANNOT BE REACHED. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH), OFLOXACIN 0.3%: 1 GTT QID X 7 DAYS, KETOROLAC 0.5%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH).

  Patient problems: Endophthalmitis; Eye Pain; Hypopyon; Loss of Vision; Vitreous Floaters

  MAUDE report 25550059 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE FACILITY REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE, THE PATIENT HAD PAIN AND BLURRED VISION. TWO (2) DAYS POST PROCEDURE, THE PATIENT PRESENTED FOR EMERGENCY CARE AT ANOTHER HEALTHCARE FACILITY WITH SEVERE PAIN AND SYMPTOMS OF ENDOPHTHALMITIS. THE PATIENT WAS HOSPITALIZED AND ON THE SECOND DAY, A VITRECTOMY WITH SILICONE OIL ADMINISTRATION WAS PERFORMED. A MICROBIOLOGICAL CULTURE IDENTIFIED ENTEROCOCCUS FAECALIS INFECTION. ANTIBIOTIC THERAPY (INCLUDING VANCOMYCIN) WAS INITIATED. FOUR (4) DAYS POST-SECONDARY PROCEDURE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH PRESERVED VISION OF 1/50, WITHOUT PAIN AND THE IOL REMAINS IMPLANTED.

  Patient problems: Blurred Vision; Endophthalmitis; Eye Pain

  MAUDE report 23435574 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ONE-DAY POST-OPERATIVE VISIT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE SURGEON NOTED THE PATIENT PRESENTED WITH 1-2+ EDEMA, SEIDEL SIGN, AND CELL 2+ FIBRIN IN AC. THIS REACTION WAS DIAGNOSED AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT'S BCVA DECREASED FROM 20/150 TO CF @ 1 FT. THE DAY AFTER SYMPTOMS WERE OBSERVED, AN INTRAVITREAL INJECTION OF VANCOMYCIN & CEFTAZIDIME WAS PERFORMED, AND A CULTURE WAS TAKEN. THE RESULT OF THE CULTURE WAS NEGATIVE. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT IS POSSIBLY FROM THE VISCO AND LIDO/PHEN. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POSTOPERATIVELY: PRED-MOXI-BROM 1%, .5%, 0.075% DOSE: 1GTT FREQUENCY: TID 2 WEEKS, BID 1 WEEK, QD 1 WEEK NEOMYCIN & POLYMYXIN & DEXAMETHASONE DOSE: 1 SMALL RIBBON FREQUENCY: ONCE PREDNISOLONE 1% DOSE:1GTT FREQUENCY: QHOURLY DURATION: UNTIL DIRECTED OTHERWISE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Vision; Swelling/ Edema; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19940749 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ONE-DAY POST-OPERATIVE VISIT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE SURGEON NOTED THE PATIENT PRESENTED WITH 1+ EDEMA, 4+ FIBRIN, AND TRACE SLIVER OF HYPOPYON. THIS REACTION WAS DIAGNOSED AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT IS POSSIBLY FROM THE VISCO AND LIDO/PHEN. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POSTOPERATIVELY: NEOMYCIN & POLYMYXIN & DEXAMETHASONE DOSE: 1 SMALL RIBBON FREQUENCY: ONCE PRED-MOXI-BROM 1%, .5%, 0.075% DOSE: 1GTT FREQUENCY: TID 2 WEEKS, BID 1 WEEK, QD 1 WEEK DUREZOL DOSE: 1GTT FREQUENCY: QHOURLY DURATION: TILL DIRECTED OTHERWISE. MOXIFLOXACIN DOSE: 1GTT FREQUENCY: QHOURLY DURATION: TILL DIRECTED OTHERWISE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypopyon; Loss of Vision; Swelling/ Edema; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19940447 ↗