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

Model Number MX60ET

Device Problem Unintended Movement (3026)

Patient Problem Blurred Vision (2137)

Event Date 05/02/2023

Event Type  Injury  

Event Description

It was reported approximately two weeks after implantation of an intraocular lens into the left eye (os) the lens rotated out of position.Lens rotation was scheduled for approximately seven weeks after initial surgery.Additional information was requested, but not received.

Manufacturer Narrative

The lens remains implanted and is not available 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.The patient had pre-existing alternating exotropia and therefore, the most probable root cause is "patient related".

• 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: 17137583
• MDR Text Key: 317298562
• Report Number: 0001313525-2023-70071
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 10757770556158
• UDI-Public: (01)10757770556158(17)250930
• 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: Physician
• Type of Report: Initial
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• 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: MXUET275+190
• Device Lot Number: 3266114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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: BAUSCH AND LOMB INJECTOR SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male