MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number MX60E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endophthalmitis (1835)

Event Date 08/31/2022

Event Type  Injury  

Event Description

Approximately 8 months post implantation patient developed bilateral precipitates on the anterior of the lens.The surgeon believes the patient has chronic endophthalmitis.

Manufacturer Narrative

Device is not available for investigation as it remains implanted in the patient¿s eye.Investigation of this event is in progress.A follow up report will be submitted upon completion of the investigation.

Event Description

Additional information from the surgeon confirmed the results of the tap performed were negative.The precipitates disappeared with a steroid with no recurrence.There is currently pigments on the patients lens.

Manufacturer Narrative

A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information the root cause of this event could not be determined.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 15604977
• MDR Text Key: 301723411
• Report Number: 0001313525-2022-00142
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: MX60E
• Device Catalogue Number: MXUE2550
• Device Lot Number: 3075836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female