MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS PRELOADED

Model Number MX60PL

Device Problem Fracture (1260)

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

Event Date 08/12/2022

Event Type  Injury  

Manufacturer Narrative

As per the reporter, the device has been discarded and is not available for analysis.A review of the device history record (dhr) did not find any non-conformities or anomalies 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 all the available information, the root cause of this event could not be determined.

Event Description

Reportedly, during an intraocular lens (iol) implant procedure there was difficulty injecting the lens and a crack was noticed in the centre of the lens optic when in the patient¿s eye.The iol was removed and replaced intraoperatively with another iol of the same model and diopter.The incision size was enlarged to 5mm to remove the iol and sutures were required.The patient outcome was not compromised.Additional information was requested but not received.

• Brand Name: ENVISTA INTRAOCULAR LENS PRELOADED
• Type of Device: INTRAOCULAR LENS
• 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: 15408538
• MDR Text Key: 299767883
• Report Number: 0001313525-2022-00117
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2022

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
• Device Operator: Health Professional
• Device Model Number: MX60PL
• Device Catalogue Number: MXPL2150
• Device Lot Number: 3241909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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: ENVISTA SIMPLIFEYE INSERTER
• Patient Outcome(s): Required Intervention