Occucoat CC065SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00757770484799), received between Nov 30, 2023 and Mar 13, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 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 IMPLANTABLE COLLAMER LENS IMPLANTATION INTO BOTH EYES, THE SURGEON NOTED THE PATIENT PRESENTED WITH SEVERE CORNEAL EDEMA, INCREASED INTRAOCULAR PRESSURE AND SYMPTOMS OF POSSIBLE TASS. THE PATIENT WAS PRESCRIBED MEDICATION TO LOWER IOP AND REFERRED TO A RETINA SPECIALIST FOR FURTHER EVALUATION OF POSSIBLE CONDITIONS. THE ORIGINAL PROCEDURE WAS NOT COMPLICATED IN ANY WAY. PROCEDURE WAS APPROXIMATELY 15-30 MINUTES. CLEAR CORNEAL INCISION UTILIZED. INCISION WAS NOT SUTURED AT THE TIME OF ORIGINAL SURGERY. CLEANING AND STERILIZATION METHODS USED PRIOR TO SURGERY: THE INSTRUMENTS WERE DECONTAMINATED AND WASHED USING MULTI-ENZYMATIC CLEANER AND DISTILLED WATER, STERILIZED USING A STEAM AUTOCLAVE. THERE WAS NO EVIDENCE OR SUSPICION OF A WOUND LEAK POSTOPERATIVELY. ANTIBIOTIC/ANTISEPTIC/STEROID MEDICATIONS USED PREOPERATIVELY: PROLENSA 1QTT BID OU 3 DAYS BEFORE SURGERY, BESIVANCE 1QTT BID OU 3 DAYS BEFORE SURGERY, LOTEMAX 1QTT 4X OU 3 DAYS BEFORE SURGERY. ANTIBIOTIC, STEROID, NSAID PRESCRIBED POSTOPERATIVELY: MOXIFLOXACIN 0.5% 1 GTT OU TID, KETOROLAC 0.5% 1 GTT OU TID, DUREZOL 0.05% 1 GTT OU QH. PATIENT UNCOOPERATIVE WITH TO

  Patient problems: Corneal Edema; Endophthalmitis; Eye Pain; Intraocular Pressure Increased; Loss of Vision

  MAUDE report 18897404 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED, INDICATING ORIGINAL PROCEDURE WAS NOT COMPLICATED IN ANY WAY. PROCEDURE WAS APPROXIMATELY 15-30 MINUTES. CLEAR CORNEAL INCISION UTILIZED. INCISION WAS NOT SUTURED AT THE TIME OF ORIGINAL SURGERY. CLEANING AND STERILIZATION METHODS USED PRIOR TO SURGERY: THE INSTRUMENTS WERE DECONTAMINATED AND WASHED USING MULTI-ENZYMATIC CLEANER AND DISTILLED WATER, STERILIZED USING A STEAM AUTOCLAVE. THERE WAS NO EVIDENCE OR SUSPICION OF A WOUND LEAK POSTOPERATIVELY. ANTIBIOTIC/ANTISEPTIC/STEROID MEDICATIONS USED PREOPERATIVELY: PROLENSA 1QTT BID OU 3 DAYS BEFORE SURGERY, BESIVANCE 1QTT BID OU 3 DAYS BEFORE SURGERY, LOTEMAX 1QTT 4X OU 3 DAYS BEFORE SURGERY. ANTIBIOTIC, STEROID, NSAID PRESCRIBED POSTOPERATIVELY: MOXIFLOXACIN 0.5% 1 GTT OU TID, KETOROLAC 0.5% 1 GTT OU TID, DUREZOL 0.05% 1 GTT OU QH. PATIENT UNCOOPERATIVE WITH TOPICAL REGIMEN DUE TO PAIN. ON POD1, PATIENT HAD SUB-TENON KENALOG INJECTION PERFORMED OU. ON POD2, PATIENT HAD PPV +INTRAVENOUS INJECTION OF ANTIBIOTICS AND ANTERIOR VIT BIOPSY OU. IN THE SURGEON''S OPINION, THE MOST LIKELY CAUSE OF EVENT IS POSTOPERATIVE INFECTION. RESULTS OF CULTURE & SENSITIVITY ARE PSEUDOMONAS AERUGINOSA SENSITIVITY. P

  Patient problems: Corneal Edema; Endophthalmitis; Eye Pain; Intraocular Pressure Increased; Loss of Vision; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 18239957 ↗