PROVISC 8065183085Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380651830851), received between Apr 23, 2021 and Nov 7, 2021 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT AFTER A CATARACT SURGERY, THE PATIENT EXPERIENCED TASS IN THE RIGHT EYE. THE PATIENT HAD NO SURGICAL COMPLICATIONS. THE PATIENT PRESENTED POST-OPERATIVELY WITH NO SIGNS OF SYMPTOMS. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED 4+ AQUEOUS CELL. THE PATIENT WAS PRESCRIBED WITH POST-OPERATIVE ANTIBIOTIC AND STEROID EYE DROPS. NO CULTURES WERE PERFORMED. THE PATIENT'S OUTCOME WAS UNKNOWN. THIS FILE REPRESENT THE FIRST PATIENT OF THREE FROM THIS FACILITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12763859 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. THE PATIENT PRESENTED POST-OPERATIVELY WITH NO SIGNS OF SYMPTOMS. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED 4+ AQUEOUS CELL AND 2+ AQUEOUS FIBRIN. THE PATIENT WAS PRESCRIBED WITH POST-OPERATIVE ANTIBIOTIC AND STEROID EYE DROPS. NO CULTURES WERE PERFORMED. THE PATIENT'S SYMPTOMS HAVE BEEN RESOLVING WITHOUT ANY ADDITIONAL TREATMENT. THIS IS THE SECOND OF FOUR REPORTS FOR THIS EVENT.

  Patient problems: Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 12763809 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IN THE RIGHT EYE FOLLOWING A CATARACT EXTRACTION PROCEDURE. THE PATIENT PRESENTED 1 DAY POST OP WITH AQUEOUS CELL AND FIBRIN. CULTURES WERE NOT TAKEN. THE PATIENT REQUIRED AN INCREASE IN THE FREQUENCY OF NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) MEDICATION. THE PATIENT IS REPORTED TO BE IMPROVING WITH TOPICAL MEDICATION ADJUSTMENT. THIS IS THE FIRST REPORT OF THREE FOR THIS PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12760704 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED AN "OUTBREAK" OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AT THEIR FACILITY. IN A FOLLOW UP WITH THE CUSTOMER, IT WAS REPORTED THAT THERE WERE FOUR PATIENTS WHO PRESENTED WITH TASS FOLLOWING OCULAR SURGERY. THERE WERE TWO SURGEON'S INVOLVED. ALL FOUR OF THE TASS CASES ALSO HAD GLAUCOMA AND THREE OF THE PATIENT'S HAD COMBINED CATARACT AND GLAUCOMA PROCEDURE. IT IS UNKNOWN AT THIS TIME WHICH SURGERY WAS PERFORMED ON WHICH PATIENT. THIS FILE REPRESENTS ONE OF THE FOUR PATIENTS.

  Patient problems: Inflammation

  MAUDE report 11760202 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED AN "OUTBREAK" OF TASS AT THEIR FACILITY. IN A FOLLOW UP WITH THE CUSTOMER, IT WAS REPORTED THAT THERE WERE FOUR PATIENTS WHO PRESENTED WITH TASS FOLLOWING OCULAR SURGERY. THERE WERE TWO SURGEON'S INVOLVED. ALL FOUR PATIENTS ASSOCIATED WITH THIS REPORT OF TASS HAD A HISTORY OF GLAUCOMA. THE EXACT PROCEDURE PERFORMED ON ANY ONE PATIENT REMAINS UNCONFIRMED. THIS FILE REPRESENTS TWO OUT OF THE FOUR PATIENTS.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 11718441 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED AN "OUTBREAK" OF TASS AT THEIR FACILITY. IN A FOLLOW UP WITH THE CUSTOMER, IT WAS REPORTED THAT THERE WERE FOUR PATIENTS WHO PRESENTED WITH TASS FOLLOWING OCULAR SURGERY. THERE WERE TWO SURGEONS INVOLVED. ALL FOUR PATIENTS ASSOCIATED WITH THIS REPORT OF TASS HAD A HISTORY OF GLAUCOMA. THE EXACT PROCEDURE PERFORMED ON ANY ONE PATIENT REMAINS UNCONFIRMED. THIS FILE REPRESENTS ONE OF THE FOUR PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713758 ↗