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

Model Number MX60ET

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2023

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation.A review of the device history record (dhr) 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 conclusively determined.

Event Description

It was reported that after implantation of an in intraocular lens (iol) into the left eye, the lens rotated out of position.The lens was repositioned, and a capsular tension ring was placed.Allegedly the lens moved out position a second time.The incision was enlarged to allow for removal of the iol and the lens was exchanged with a different model iol.There were no injuries reported.In the surgeon's opinion the most likely cause for event is haptic not contacting capsular bag adequately.

• 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 ; 21 n park pl blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 17270634
• MDR Text Key: 318494831
• Report Number: 0001313525-2023-70087
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MX60ET
• Device Catalogue Number: MXUET350+180
• Device Lot Number: 3242431
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2022
• 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: FORTIFEYE CTR
• Patient Outcome(s): Required Intervention