MAUDE Adverse Event Report: BAUSCH + LOMB AMVISC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Model Number	59081L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare facility reported that the patient had elevated intraocular pressure (iop) following uncomplicated cataract surgery in the right eye.The iop prior to surgery was 15mmhg.The iop was elevated postoperatively at 60mmhg and the increased iop lasted for eight (8) weeks and is currently high at 32 mmhg.Patient was treated with maximum medical treatment.The patient has not recovered.
Additional Manufacturer Narrative
The device was discarded.The investigation is ongoing.
Additional Manufacturer Narrative
The device was discarded.The device history record (dhr) review did not find any non-conformities or anomalies related to this event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be determined.
Event or Problem Description
The patient was treated with latanaprost, cosopt and iopidine, which is still required to control the intraocular pressure (iop).

• Brand Name: AMVISC VISCOSURGICAL DEVICE
• 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 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 16324440
• Report Number: 0001313525-2023-00018
• Device Sequence Number: 15614720
• Product Code: LZP
• UDI-Device Identifier: 00757770495658
• UDI-Public: (01)00757770495658(17)250331(10)029686
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P810025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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: 03/31/2025
• Device Model Number: 59081L
• Device Catalogue Number: 59081L
• Device Lot Number: 029686
• 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
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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: STELLARIS SYSTEM, EYEC1CRYPRE2450, BSS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown