MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Vision (2139); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported one day post implantation of an intraocular lens (iol) into the left (os) eye, the patient experienced symptoms that were later diagnosed as tass.Slit lamp findings found fibrin in the ac, and the patient had a decrease in vision.A culture was taken.An intravitreal steroid injection was administered two days post implant.The results of the culture and sensitivity were negative.In the surgeon's opinion, the likely cause of the event was the iol.The patient's outcome is good.Additional information has been requested but has not been received.
Additional Manufacturer Narrative
As the device remains implanted in the eye, the device was not evaluated.A review of the device history record (dhr), did not find any anomalies or nonconformities related to the reported event.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, a root cause could not be determined.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 20359850
• Report Number: 0001313525-2024-00158
• Device Sequence Number: 12765457
• Product Code: HQL
• UDI-Device Identifier: 10757770531186
• UDI-Public: (01)10757770531186(17)261130(11)231210(10)3P34456
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 09/04/2024

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 Model Number: MX60E
• Device Catalogue Number: MXUE1650
• Device Lot Number: 3P34456
• 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: 09/04/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2023
• 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: CLEARVISC VISCOELASTIC, NON B+L INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male