MAUDE Adverse Event Report: BAUSCH + LOMB OCUCOAT VISCOELASTIC; AID, SURGICAL, VISCOELASTIC

Model Number	CC065S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Endophthalmitis (1835); Intraocular Pressure Increased (1937); Loss of Vision (2139); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation and additional information regarding the event was not provided.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
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.During the patient's surgery two units were used individually, one unit was used for right eye and one unit was used on left eye.Additional information was requested, but not received.
Event or Problem Description
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.Patient outcome is poor due to nature of severe infection, caused by p.Aeruginosa endophthalmitis.
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
This is the report for the right eye (od).Left eye (os) reference:0001313525-2024-70065.
Additional Manufacturer Narrative
The device involved in this event was not returned for evaluation.Two unused units from the same lot were returned and evaluated.Evaluation of the returned product confirmed that all packaging seals were intact for each component (cannula needle and retention clip) and syringe.No seals were broken and there were no visible integrity or appearance issues with any of the components or syringes.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause could not be conclusively determined.

• Brand Name: OCUCOAT VISCOELASTIC
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): LIFECORE BIOMEDICAL; 3515 lyman blvd.; chaska MN 55318
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 18239957
• Report Number: 0001313525-2023-70130
• Device Sequence Number: 3225195
• Product Code: LZP
• UDI-Device Identifier: 00757770484799
• UDI-Public: (01)00757770484799(17)250930(10)029923
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P860047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: CC065S
• Device Lot Number: 029923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/26/2024; 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ICL LENS; LIOLI-24 INJECTOR, BETADINE-IODINE, MOXIFLOXACIN PF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female