MAUDE Adverse Event Report: BAUSCH + LOMB TRULIGN TORIC POSTERIOR CHAMBER IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number BL1UT

Device Problem Unintended Movement (3026)

Patient Problems Blurred Vision (2137); Loss of Vision (2139)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported 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 Description

It was reported that the patient had an intraocular lens (iol) implanted the right eye (od).Femtosecond laser was used for the corneal incision, capsulorhexis and lens fragmentation.The patient developed blurry vision due to bilateral asymmetric z-syndrome with significant tilt.Right eye (od) yag capsulotomy was performed at approximately 1.5 months and 2.5 months post-implant.Due to a decrease in bcva and z-syndrome, the right lens (od) was explanted approximately 4 months post implant.The original iol was replaced with different model and diopter, sulcus fixed lens.

• Brand Name: TRULIGN TORIC POSTERIOR CHAMBER IOL
• 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 ; 21 north park place blvd.; clearwater, FL 33759
• MDR Report Key: 13869095
• MDR Text Key: 287910969
• Report Number: 0001313525-2022-00035
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: BL1UT
• Device Catalogue Number: BL1UT2150125
• Device Lot Number: 222
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male