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 05/24/2022

Event Type  Injury  

Manufacturer Narrative

The lens remains implanted and is not available for investigation.Additional information was requested, but not received.As a serial number for the device was not provided, the associated device history record was not reviewed.The 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 conclusively determined.

Event Description

Medwatch report 5115006 was received.Reportedly a consumer experienced iol rotation three weeks after implantation of an intraocular lens into the right eye.The lens was repositioned and allegedly moved out of position a second time.Reportedly, the surgeon would not reposition the lens a second time.Additional information has been requested, but not received.

Event Description

Additional information received, indicating the event was caused by z-syndrome, and a toric iol rotation event did not take place.

Manufacturer Narrative

Additional information: a2, b5, g3, h2, h10/11.

• 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 ; 7277246600
• MDR Report Key: 16599248
• MDR Text Key: 311930525
• Report Number: 0001313525-2023-70038
• 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: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL1UT
• Device Catalogue Number: BL1UT
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR
• Patient Sex: Female