MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB IOL INJECTOR; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number INJ100

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 02/21/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.The investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

Event Description

It was reported that an iol was introduced into the patient's eye with the leading haptic sticking out and the trailing haptic stuck in the injector.During insertion, the trailing haptic then broke.The surgeon decided to cut the iol in half and remove from the eye.The incision was enlarged.An iol of the same model and diopter was inserted successfully.In the surgeon's opinion, the likely cause of the event was incorrect loading.

Manufacturer Narrative

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 conclusively determined; however, user-related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have caused or contributed to the event.

• Brand Name: BAUSCH + LOMB IOL INJECTOR
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 7277246600
• MDR Report Key: 16589388
• MDR Text Key: 311738487
• Report Number: 0001313525-2023-70036
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00757770505326
• UDI-Public: (01)00757770505326(17)240828
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

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: INJ100
• Device Lot Number: 2253A2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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 IOL.
• Patient Outcome(s): Required Intervention