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

Model Number MX60T

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation.The inserter used was not identified so we are unable to determine if a validated inserter was used.A review of device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The risk analysis and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.

Event Description

It was reported that during an implantation of an intraocular lens (iol) into the eye a haptic arm was stuck to the lens.During the process of releasing the haptic from the lens, the haptic tore at the optic-haptic junction.The incision was enlarged to allow for removal of the iol and the lens was replaced intraoperatively with a backup lens of the same model and diopter.Sutures were not required.There were no injuries reported.The patient has recovered.

Manufacturer Narrative

Additional information was received confirming use of an unvalidated injector.

Event Description

Additional information was received confirming the type of injector used.

• 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 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 17236919
• MDR Text Key: 318182251
• Report Number: 0001313525-2023-70080
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 10757770517203
• UDI-Public: (01)10757770517203(17)250531
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MX60T
• Device Catalogue Number: MX60TP200+240
• Device Lot Number: 3254813
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2022
• 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: SIMPLIFEYE INSERTER FOR ENVISTA
• Patient Outcome(s): Required Intervention