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

Model Number INJ100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Disturbances (2140)

Event Date 07/10/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.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 all the available information, the root cause of this event could not be determined.

Event Description

It was reported that the leading haptic of the intraocular lens (iol) was torn off during folding, and this was noticed when the lens unfolded in the eye.An attempt was made to position the lens and leave in the eye however there was an optically disturbing effect due to the tilting of lens.One (1) month later the lens was explanted, and a new lens was implanted.The patient is doing well with the new iol and is very satisfied.Additional information was requested but not received.

Event Description

Additional information was received indicating that report relates to the patient¿s left eye.The replacement iol was a preloaded lens with the same model and diopter.The patient has not noticed a decrease in their vision.

Manufacturer Narrative

Additional info: a2, a3, b5, b6, g3, g6, h2, h10/11.

• 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 ; clearwater, FL ; 7277246600
• MDR Report Key: 18191013
• MDR Text Key: 328791650
• Report Number: 0001313525-2023-70128
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00757770505326
• UDI-Public: (01)00757770505326(17)250331(10)22136B11
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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: 22136B11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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, EYEFILLC, CORNEAPRO
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male