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

Model Number BL1UT

Device Problem Unintended Movement (3026)

Patient Problem Visual Impairment (2138)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation.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, patient related factors may have caused or contributed to this event.

Event Description

Reportedly, the patient had cataract surgery and approximately a month later the patient developed sudden blurry vision in their left eye.Capsular fibrosis was observed and the patient had an iol exchange with a different model lens 5 months from the original surgery due to z-syndrome.A capsular tension ring was used for the lens exchange.The physicians opinion for the cause of vaulting was capsular fibrosis.

• 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 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759
• MDR Report Key: 15064408
• MDR Text Key: 296214132
• Report Number: 0001313525-2022-00095
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• 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: BL1UT2700275
• 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: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• 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: 70 YR