MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS PRELOADED

Model Number MXPLC

Device Problem Material Deformation (2976)

Patient Problem Blurred Vision (2137)

Event Date 10/25/2021

Event Type  Injury  

Event Description

Reportedly, an iol was removed during an emergency procedure three weeks post-op, and replaced with another lens of the same model and diopter due to an alleged defect in the lens.The patient had mild slight double vision and lines were a bit crooked.Glasses were prescribed three months post lens exchange to mitigate the slight double vision.Additional information has been requested, and not received.

Manufacturer Narrative

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

• Brand Name: ENVISTA INTRAOCULAR LENS PRELOADED
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 n park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd., jambalana drive; clearwater, FL 33759
• MDR Report Key: 13513676
• MDR Text Key: 285457502
• Report Number: 0001313525-2022-00014
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: MXPLC
• Device Catalogue Number: MXPLC1850
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENVISTA SIMPLIFEYE INJECTOR
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male