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

Model Number	MX60TP
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Failure to Eject (4010)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.Additional information was requested but not received.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, the root cause of this event could not be determined.
Event or Problem Description
It was reported that during a cataract surgery the intraocular lens was stuck in the injector.The injector was removed from the eye, the iol was removed from the injector and transferred to another injector of a different model.During the implantation with the replacement injector a ruptured posterior capsule was observed.An anterior vitrectomy was performed to remove the vitreous.The main incision was enlarged before the iol implantation.The lens remains implanted in the eye and a follow-up appointment is planned to check that the lens is in the correct position.Although requested additional information was not obtained.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Common Device Name: 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: 19123076
• Report Number: 0001313525-2024-00085
• Device Sequence Number: 8248929
• Product Code: MJP
• UDI-Device Identifier: 10757770517487
• UDI-Public: (01)10757770517487(17)260630
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: MX60TP
• Device Catalogue Number: MX60TP275+130
• Device Lot Number: 3P20701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INJ100, VISCOJECT BIO 2.2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown