MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA TORIC INTRAOCULAR LENS; LENS, INTRAOCULAR, TORIC OPTICS

Model Number MX60PT

Device Problem Break (1069)

Patient Problems Corneal Decompensation (1790); Corneal Edema (1791)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as it remains implanted.A review of the device history record did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis, 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 of this event could not be determined.

Event Description

It was reported that a patient had corneal decompensation approximately five months after a toric iol implantation.There were no abnormalities notes during the initial implantation procedure.Approximately three weeks postop, corneal edema was noted.The patient was referred for a second opinion and it was noted that a broken piece of haptic was found in the anterior chamber, causing an abrasion to the corneal endothelium, which led to decompensation.The lens remains implanted in the patient's eye.The patient had a dsaek procedure and has recovered.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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
• MDR Report Key: 13770525
• MDR Text Key: 287193914
• Report Number: 0001313525-2022-00030
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: MX60PT
• Device Catalogue Number: MXPT200+215
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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 INSERTER
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR